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)

CERION HAND HELD OXYGEN ANALYZER

K-Number: K911344 · 1991-06-18

ApplicantCeramatec, Inc.
Decision Date1991-06-18
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CERION HAND HELD OXYGEN ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Ceramatec, Inc.. It received FDA 510(k) clearance on 1991-06-18 under 510(k) number K911344. 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 CERION HAND HELD OXYGEN ANALYZER?

CERION HAND HELD OXYGEN ANALYZER is a medical device that received FDA 510(k) clearance on 1991-06-18. The listed applicant is Ceramatec, Inc.. The 510(k) number is K911344.

When did CERION HAND HELD OXYGEN ANALYZER receive FDA 510(k) clearance?

CERION HAND HELD OXYGEN ANALYZER received FDA 510(k) clearance on 1991-06-18, under 510(k) number K911344.

Who is the listed applicant for CERION HAND HELD OXYGEN ANALYZER?

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 CERION HAND HELD OXYGEN ANALYZER?

The FDA product code for CERION HAND HELD OXYGEN ANALYZER 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.

K972992CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORSK973282HANDI 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.

↑