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FDA 510(k)

FLUID WARMER

K-Number: K842302 · 1984-08-27

ApplicantOrganon Teknika Corp.
Decision Date1984-08-27
Product CodeFLA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLUID WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1984-08-27 under 510(k) number K842302. 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 FLUID WARMER?

FLUID WARMER is a medical device that received FDA 510(k) clearance on 1984-08-27. The listed applicant is Organon Teknika Corp.. The 510(k) number is K842302.

When did FLUID WARMER receive FDA 510(k) clearance?

FLUID WARMER received FDA 510(k) clearance on 1984-08-27, under 510(k) number K842302.

Who is the listed applicant for FLUID WARMER?

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

What is the FDA product code for FLUID WARMER?

The FDA product code for FLUID WARMER is FLA.

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Other records listing Organon Teknika Corp. as applicant

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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.

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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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