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)

CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS

K-Number: K972992 · 1998-03-30

ApplicantCeramatec, Inc.
Decision Date1998-03-30
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS is the device name listed in this FDA 510(k) record. The listed applicant is Ceramatec, Inc.. It received FDA 510(k) clearance on 1998-03-30 under 510(k) number K972992. 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 CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS?

CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS is a medical device that received FDA 510(k) clearance on 1998-03-30. The listed applicant is Ceramatec, Inc.. The 510(k) number is K972992.

When did CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS receive FDA 510(k) clearance?

CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS received FDA 510(k) clearance on 1998-03-30, under 510(k) number K972992.

Who is the listed applicant for CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS?

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

What is the FDA product code for CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS?

The FDA product code for CERAMATEC MAXCELL AND CAG 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

Other records listing Ceramatec, Inc. as applicant

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.

K973282HANDI OXYGEN ANALYZERK911344CERION HAND HELD OXYGEN ANALYZERK880448CERION OXY THRESHOLD ALARM

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.

↑