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FDA 510(k)

THERMOMETER, SINGLE USE, STRIP, TEMPADOT

K-Number: K771038 · 1977-06-27

ApplicantOrganon, Inc.
Decision Date1977-06-27
Product CodeFQZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THERMOMETER, SINGLE USE, STRIP, TEMPADOT is the device name listed in this FDA 510(k) record. The listed applicant is Organon, Inc.. It received FDA 510(k) clearance on 1977-06-27 under 510(k) number K771038. The device is classified under product code FQZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMOMETER, SINGLE USE, STRIP, TEMPADOT?

THERMOMETER, SINGLE USE, STRIP, TEMPADOT is a medical device that received FDA 510(k) clearance on 1977-06-27. The listed applicant is Organon, Inc.. The 510(k) number is K771038.

When did THERMOMETER, SINGLE USE, STRIP, TEMPADOT receive FDA 510(k) clearance?

THERMOMETER, SINGLE USE, STRIP, TEMPADOT received FDA 510(k) clearance on 1977-06-27, under 510(k) number K771038.

Who is the listed applicant for THERMOMETER, SINGLE USE, STRIP, TEMPADOT?

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

What is the FDA product code for THERMOMETER, SINGLE USE, STRIP, TEMPADOT?

The FDA product code for THERMOMETER, SINGLE USE, STRIP, TEMPADOT is FQZ.

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Related Devices (Code: FQZ)

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.

K110305CRY-ACTRACKERCAMBrymill Cryogenic CystemsK963049STERI-AID KITSteri-Aid, Inc.K946046DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIPDeroyal Critical Care, Div. Deroyal TechnologiesK894893POINT CHECKER COLOR STRIP THERMOMETERKyowa Medex Co., Ltd.K884612FRANKLIN COLLECTOR(R)Franklin Diagnostics, Inc.K881286TEMPA-DOT CLINICAL THERMOMETER SHEATHPymah 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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