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FDA 510(k)

FLO-TEMP

K-Number: K810021 · 1981-01-23

ApplicantLaminar Flow Industries
Decision Date1981-01-23
Product CodeFLA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLO-TEMP is the device name listed in this FDA 510(k) record. The listed applicant is Laminar Flow Industries. It received FDA 510(k) clearance on 1981-01-23 under 510(k) number K810021. The device is classified under product code FLA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLO-TEMP?

FLO-TEMP is a medical device that received FDA 510(k) clearance on 1981-01-23. The listed applicant is Laminar Flow Industries. The 510(k) number is K810021.

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

FLO-TEMP received FDA 510(k) clearance on 1981-01-23, under 510(k) number K810021.

Who is the listed applicant for FLO-TEMP?

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

What is the FDA product code for FLO-TEMP?

The FDA product code for FLO-TEMP is FLA.

Related Devices (Code: FLA)

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.

K842302FLUID WARMEROrganon Teknika Corp.

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.

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