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FDA 510(k)

CERION OXY THRESHOLD ALARM

K-Number: K880448 · 1988-03-21

ApplicantCeramatec, Inc.
Decision Date1988-03-21
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CERION OXY THRESHOLD ALARM is the device name listed in this FDA 510(k) record. The listed applicant is Ceramatec, Inc.. It received FDA 510(k) clearance on 1988-03-21 under 510(k) number K880448. 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 OXY THRESHOLD ALARM?

CERION OXY THRESHOLD ALARM is a medical device that received FDA 510(k) clearance on 1988-03-21. The listed applicant is Ceramatec, Inc.. The 510(k) number is K880448.

When did CERION OXY THRESHOLD ALARM receive FDA 510(k) clearance?

CERION OXY THRESHOLD ALARM received FDA 510(k) clearance on 1988-03-21, under 510(k) number K880448.

Who is the listed applicant for CERION OXY THRESHOLD ALARM?

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 OXY THRESHOLD ALARM?

The FDA product code for CERION OXY THRESHOLD ALARM 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 ANALYZERK911344CERION HAND HELD OXYGEN ANALYZER

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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