Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021343210

FEI Number

3021343210

Entity Name

OSI SYSTEMS PVT LTD(OPTOELECTRONICS DIVISION)

City/State/Country

HYDERABAD Telangana, IN

Establishment Address

1st and 2nd floor, GMR Aero Tower-2, Sy, No. 99/1, Mamidipally Village, Saroornagar Mandal, Ranga Reddy Distt (Near RGIA), HYDERABAD Telangana 500108, IN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

OSI Systems Pvt. Ltd(Optoelectronics division) (Owner Number: 9096780)

Owner / Operator Contact Address

1st and 2nd floor, GMR Aero Tower-2,, Sy, No. 99/1 (Near RGIA) Mamidipally Village, Saroornagar Mandal, Ranga Reddy Distt, Hyderabad, IN-TG 500108, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

7000X 6000CX ADULT SPOT -CHECK SENSOR(WW1000,WW1020,WW1030) PROBE FINGER PEDIATRIC RE-USABLE FINGER PROBE - OXIMETRY OXIMETRY PROBE UNIVERSAL Y OXIMETRY EAR PROBE DISPOSABLE PROBE 8203CA 8204CA PROBE FINGER PEDIATRIC RE-USABLE (CONFIDENTIAL) Dolphin Digital Sensors OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM SENSOR OXIM FNGR PRB COMFORT CLIP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-08-23
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-03-04
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-03-04
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2012-03-15
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2012-03-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-03-04
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-12-10
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-03-15
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2015-07-13
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2012-03-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-03-04
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2018-08-23
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2012-03-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2013-01-28
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2008-03-04
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2012-09-27
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-12-10
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2017-04-10
DQH	Cardiograph, Apex (Vibrocardiograph)	Cardiovascular	Class 2	870.2310	2012-03-15

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Jardim Email: KJardim@osioptoelectronics.com Phone: (310) 3492624

Related Public Records

Same Entity

OSI Systems Pvt. Ltd(Optoelectronics 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

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3013418500	Quintana Supply, a division of Thomas Scientific	Haverhill, MA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021343210. Last updated year: 2026. Please use registration number 3021343210 when referencing this establishment in official correspondence.