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FDA 510(k)

HANDI OXYGEN ANALYZER

K-Number: K973282 · 1998-03-04

ApplicantCeramatec, Inc.
Decision Date1998-03-04
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HANDI 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 1998-03-04 under 510(k) number K973282. 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 HANDI OXYGEN ANALYZER?

HANDI OXYGEN ANALYZER is a medical device that received FDA 510(k) clearance on 1998-03-04. The listed applicant is Ceramatec, Inc.. The 510(k) number is K973282.

When did HANDI OXYGEN ANALYZER receive FDA 510(k) clearance?

HANDI OXYGEN ANALYZER received FDA 510(k) clearance on 1998-03-04, under 510(k) number K973282.

Who is the listed applicant for HANDI 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 HANDI OXYGEN ANALYZER?

The FDA product code for HANDI 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 SENSORSK911344CERION 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

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

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