Data / Medical devices / United States / Osi Optoelectronics (medical Division)

Osi Optoelectronics (medical Division): FDA-registered device maker in Hawthorne, CA, United States, 6 510(k) clearances

Name: Osi Optoelectronics (medical Division) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Osi Optoelectronics (medical Division) is registered with the FDA (registration 3006713849) in Hawthorne, CA, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 15, 2006. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3006713849
Address: 12525 Chadron Ave, Hawthorne, CA, United States, 90250
Owner or operator: OSI Optoelectronics (Medical Division) (10024288)
Roles: Contract manufacturer, Specification developer
First device listed: July 6, 2010
Registered through: 2027
Brand names listed: Adroit Surgical, Dolphin

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Contract manufacturer	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Contract manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Contract manufacturer, Specification developer	accessdata.fda.gov
Oximeter, Ear	DPZ	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 15, 2006	K060524	DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES	DQA	Substantially Equivalent	Dolphin Medical, Inc.	accessdata.fda.gov
March 11, 2004	K033876	DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422	DQA	Substantially Equivalent	Dolphin Medical, Inc.	accessdata.fda.gov
October 17, 2003	K032947	NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210	DQA	Substantially Equivalent	Dolphin Medical, Inc.	accessdata.fda.gov
September 4, 2003	K030629	DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER	DQA	Substantially Equivalent	Dolphin Medical, Inc.	accessdata.fda.gov
May 19, 2003	K030952	DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421	DQA	Substantially Equivalent	Dolphin Medical, Inc.	accessdata.fda.gov
March 20, 2002	K012989	DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070	DQA	Substantially Equivalent	Dolphin Medical, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 15, 2006. 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.