FDA 510(k)

FLO-COR I

K-Number: K812825 · 1981-10-26

Decision Date1981-10-26

Product CodeJAX

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

FLO-COR I is the device name listed in this FDA 510(k) record. The listed applicant is Biotrine Corp.. It received FDA 510(k) clearance on 1981-10-26 under 510(k) number K812825. The device is classified under product code JAX. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLO-COR I?

FLO-COR I is a medical device that received FDA 510(k) clearance on 1981-10-26. The listed applicant is Biotrine Corp.. The 510(k) number is K812825.

When did FLO-COR I receive FDA 510(k) clearance?

FLO-COR I received FDA 510(k) clearance on 1981-10-26, under 510(k) number K812825.

Who is the listed applicant for FLO-COR I?

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

What is the FDA product code for FLO-COR I?

The FDA product code for FLO-COR I is JAX.

Other records listing Biotrine Corp. 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.

K915060ASTECH HOME PEAK FLOW METER K883704MULTIICHALLENGE NEBULIZER SYSTEM K863134MULTISPIRO SA/100 K844226B-1000 K813414PEAK FLOW MONITOR

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K990962FLOSENSE, MODEL 29-8010Sdi Diagnostics, Inc.K921178PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHSMedical Associated Services, Inc.K884464SPIROMETRICS MODEL 2200 SM200 FLOW SENSORSpirometrics, Inc.K853085PAX METERPeace Medical, Inc.K833265RESPIRATORY FLOW MODULEThoratec Laboratories Corp.K791730RING-ORIFICE, TURBULENT FLOW PNEUMOTResearch Development Corp.

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.