OSI OPTOELECTRONICS (MEDICAL DIVISION)

FDA Device Registration & Listing · Hawthorne, CA, US · Registration 3006713849

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006713849
FEI Number
3006713849
Entity Name
OSI OPTOELECTRONICS (MEDICAL DIVISION)
City/State/Country
Hawthorne, CA, US
Establishment Address
12525 Chadron Ave, Hawthorne, CA 90250, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
OSI Optoelectronics (Medical Division) (Owner Number: 10024288)
Owner / Operator Contact Address
12525 Chadron Ave, Hawthorne, CA 90250, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K012989
PMA Number
N/A

All Registered Proprietary Names

Dolphin Dolphin Dolphin Dolphin

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2010-07-06
DQA Oximeter Cardiovascular Class 2 870.2700 2015-07-10
DQA Oximeter Cardiovascular Class 2 870.2700 2010-07-06
DQA Oximeter Cardiovascular Class 2 870.2700 2015-07-10
DQA Oximeter Cardiovascular Class 2 870.2700 2010-07-06
DQA Oximeter Cardiovascular Class 2 870.2700 2013-01-28
DQA Oximeter Cardiovascular Class 2 870.2700 2010-07-06
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2015-07-10
DQA Oximeter Cardiovascular Class 2 870.2700 2010-07-06

Official Correspondent

Kevin Jardim

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OSI Optoelectronics (Medical Division)
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31
K971628 Somanetics Corp. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 1997-10-10
K153184 Shenzhen Caremed Medical Technology Co., Ltd. Caremed Reusable & Disposable SPO2 Sensors 2017-01-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

Registration Number Establishment Name Location
3014652024 CEA GROUP INTERNATIONAL CO.,LTD Wenzhou Zhejiang, CN
1062836 DIGICARE BIOMEDICAL TECHNOLOGY, INC. BOYNTON BEACH, FL, US
3013250653 MASIMO CORPORATION Irvine, CA, US
3013418500 Quintana Supply, a division of Thomas Scientific Haverhill, MA, US
9614470 RADIOMETER BASEL AG BASEL Basel-Stadt, CH
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006713849. Last updated year: 2026. Please use registration number 3006713849 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.