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Data / Medical devices / Computer, Oxygen-Uptake

Computer, Oxygen-Uptake (BZL): 21 FDA-registered makers in 9 countries

21 establishments in 9 countries are registered with the FDA to make Computer, Oxygen-Uptake (product code BZL, Class 2, 21 CFR 868.1730). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 33 510(k) clearances under this code, the latest on September 25, 2020, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
BZL
Device class
2
Regulation
868.1730
Medical specialty
Anesthesiology

Makers by country

CountryMakers
United States8
Taiwan3
China3
Finland2
Italy1
Germany1
Mexico1
United Kingdom1
Estonia1

Makers of Computer, Oxygen-Uptake

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
Aei Technologies Inc.Bastrop, TX, United StatesManufacturer2April 8, 1993000api.fda.gov
Medical Graphics Corp.Saint Paul, MN, United StatesManufacturer2April 16, 2007000api.fda.gov
Microlife Corp.Taipei, TaiwanSpecification developer2June 14, 2002000api.fda.gov
Cosmed S.R.L.Albano Laziale, Roma, ItalyManufacturer1September 28, 2007000api.fda.gov
Jaeger Medical GmbHHOECHBERG Bavaria, GermanyComplaint file establishment, Manufacturer1February 5, 1986000api.fda.gov
Korr Medical Technologies, Inc.Salt Lake City, UT, United StatesManufacturer1January 2, 2003000api.fda.gov
TF Health Corp.Phoenix, AZ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1September 25, 2020000api.fda.gov
Vacumed, Div. Of Vacumetrics, Inc.Ventura, CA, United StatesManufacturer1March 4, 1987000api.fda.gov
Amphenol Medical Technologies (Dongguan) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Ge Healthcare Finland OYHELSINKI Uusimaa, FinlandManufacturer, Specification developer0000api.fda.gov
Ge Medical Systems (china) Co., Ltd.WUXI Jiangsu, ChinaSpecification developer0000api.fda.gov
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.JUAREZ Chihuahua, MexicoManufacturer0000api.fda.gov
KB Components Finland OyNurmijarvi Etela-Karjala, FinlandContract manufacturer0000api.fda.gov
Medipines CorporationYorba Linda, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Mehow Innovative LtdShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Platinum Focus Group Ltd.London London, City of, United KingdomExporter to the US, Manufacturer0000api.fda.gov
RAUMEDIC Estonia ASTallinn Harjumaa, EstoniaContract manufacturer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Technical Services for Electronics, Inc.New Taipei City, TaiwanContract manufacturer0000api.fda.gov
TreyMed, Inc.Sussex, WI, United StatesContract manufacturer0000api.fda.gov
Wholecare Biomedical CorporationTaipei City, TaiwanContract manufacturer0000api.fda.gov

Updated September 25, 2020. 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.