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Data / Medical devices / Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)

Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) (CBR): 43 FDA-registered makers in 14 countries

43 establishments in 14 countries are registered with the FDA to make Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) (product code CBR, Class 2, 21 CFR 868.1700). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on October 5, 2011, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
CBR
Device class
2
Regulation
868.1700
Medical specialty
Anesthesiology

Makers by country

CountryMakers
United States14
China7
Germany5
Finland3
Japan3
Mexico2
India2
Singapore1
Sweden1
Poland1
Malaysia1
United Kingdom1
Estonia1
Taiwan1

Makers of Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesManufacturer2October 5, 2011030api.fda.gov
Jaeger Medical GmbHHOECHBERG Bavaria, GermanyComplaint file establishment, Manufacturer1September 3, 1985000api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesManufacturer0000api.fda.gov
AirLife Finland OyHelsinki Uusimaa, FinlandComplaint file establishment, Specification developer0000api.fda.gov
Amphenol Medical Technologies (Dongguan) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Caf Medical Solutions IncHockley, TX, United StatesManufacturer0000api.fda.gov
Draeger Medical Systems, Inc.Andover, MA, United StatesManufacturer0000api.fda.gov
Draeger Interservices GmbHLuebeck Schleswig-Holstein, GermanyContract manufacturer0000api.fda.gov
Draegerwerk AG & Co. KGaALUEBECK Schleswig-Holstein, GermanySpecification developer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Edan Instruments, Inc.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Flextronics Manufacturing (Singapore) Pte LtdSINGAPORE South East, SingaporeContract manufacturer0000api.fda.gov
Frohe Sweden ABTyreso, SwedenContract manufacturer0000api.fda.gov
Ge Healthcare Finland OYHELSINKI Uusimaa, FinlandManufacturer, Specification developer0000api.fda.gov
Ge Medical Systems (china) Co., Ltd.WUXI Jiangsu, ChinaManufacturer, Specification developer0000api.fda.gov
Ge Medical Systems Information TechnologiesEl Paso, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.JUAREZ Chihuahua, MexicoManufacturer0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Waukesha, WI, United StatesSpecification developer0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Wauwatosa, WI, United StatesSpecification developer0000api.fda.gov
Guangdong Biolight Meditech Co., LtdZhuhai Guangdong, ChinaManufacturer0000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Industrial Vallera de Mexicali, S. A. de C. V.Mexicali Mexico, MexicoManufacturer0000api.fda.gov
KB Components Finland OyNurmijarvi Etela-Karjala, FinlandContract manufacturer0000api.fda.gov
Kimball Electronics Poland Sp.z o.oTarnowo Podgorne Wielkopolskie, PolandContract manufacturer0000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
Masimo Medical Technologies (Malaysia) SDN BHDPasir Gudang Johor, MalaysiaComplaint file establishment, Manufacturer0000api.fda.gov
Nihon Kohden Corp.SHINJUKU-KU Tokyo, JapanSpecification developer0000api.fda.gov
Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology CenterTokorozawa Saitama, JapanComplaint file establishment, Specification developer0000api.fda.gov
Nihon Kohden Tomioka CorporationGunma Tokyo, JapanManufacturer0000api.fda.gov
Platinum Focus Group Ltd.London London, City of, United KingdomExporter to the US, Manufacturer0000api.fda.gov
Pulsion Medical Systems SeAschheim, GermanyContract manufacturer0000api.fda.gov
Philips Medizin Systeme Boeblingen GmbHBOEBLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCExport, PA, United StatesContract manufacturer0000api.fda.gov
RAUMEDIC Estonia ASTallinn Harjumaa, EstoniaContract manufacturer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Shenzhen Comen Medical Instruments Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Skanray Technologies LimitedMysore Karnataka, IndiaComplaint file establishment, Manufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co.,LTDSHENZHEN Guangdong, ChinaExporter to the US, Specification developer0000api.fda.gov
Technical Services for Electronics, Inc.New Taipei City, TaiwanContract manufacturer0000api.fda.gov
Wipro Ge Medical Device Manufacturing Private LimitedBangalore Karnataka, IndiaManufacturer0000api.fda.gov

Updated October 5, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.