QOSTRONICS INC

FDA Device Registration & Listing · San Jose, CA, US · Registration 3008717564

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
3008717564
FEI Number
3008717564
Entity Name
QOSTRONICS INC
City/State/Country
San Jose, CA, US
Establishment Address
2044 Corporate Court, San Jose, CA 95131, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
QOSTRONICS INC (Owner Number: 10054963)
Owner / Operator Contact Address
2044 Corporate Court, San Jose, CA 95131, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K081233
PMA Number
N/A

All Registered Proprietary Names

Oximeter, tissue saturation

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2017-05-18

Official Correspondent

Emma Fernandez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

QOSTRONICS INC
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
K201432 Masimo Corporation Masimo O3 Regional Oximeter System 2020-08-29
K211561 Covidien, LLC INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) 2021-12-05

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008717564. Last updated year: 2026. Please use registration number 3008717564 when referencing this establishment in official correspondence.
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