Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS

K-Number: K953351 · 1995-10-16

ApplicantSeatronics Co.
Decision Date1995-10-16
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS is the device name listed in this FDA 510(k) record. The listed applicant is Seatronics Co.. It received FDA 510(k) clearance on 1995-10-16 under 510(k) number K953351. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS?

SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS is a medical device that received FDA 510(k) clearance on 1995-10-16. The listed applicant is Seatronics Co.. The 510(k) number is K953351.

When did SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS receive FDA 510(k) clearance?

SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS received FDA 510(k) clearance on 1995-10-16, under 510(k) number K953351.

Who is the listed applicant for SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS?

The FDA 510(k) record lists Seatronics Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS?

The FDA product code for SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS is CCL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: CCL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter LabsK251245OxyMinder Pro (10310)Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLCK221734Maxtec MaxO2 ME+pMaxtec, LLCK213933Percent Oxygen SensorsCareox, LLCK213948OxyMinderBio-Med Devices, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑