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FDA 510(k)

FLO TEM (FLUID WARNER)

K-Number: K800699 · 1980-05-08

ApplicantChroma Products, Inc.
Decision Date1980-05-08
Product CodeKZL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FLO TEM (FLUID WARNER) is the device name listed in this FDA 510(k) record. The listed applicant is Chroma Products, Inc.. It received FDA 510(k) clearance on 1980-05-08 under 510(k) number K800699. The device is classified under product code KZL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLO TEM (FLUID WARNER)?

FLO TEM (FLUID WARNER) is a medical device that received FDA 510(k) clearance on 1980-05-08. The listed applicant is Chroma Products, Inc.. The 510(k) number is K800699.

When did FLO TEM (FLUID WARNER) receive FDA 510(k) clearance?

FLO TEM (FLUID WARNER) received FDA 510(k) clearance on 1980-05-08, under 510(k) number K800699.

Who is the listed applicant for FLO TEM (FLUID WARNER)?

The FDA 510(k) record lists Chroma Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLO TEM (FLUID WARNER)?

The FDA product code for FLO TEM (FLUID WARNER) is KZL.

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Related Devices (Code: KZL)

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.

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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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