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FDA 510(k)

HEALTHCHECK THERM-STRIP

K-Number: K863181 · 1986-09-11

ApplicantHealthcheck Corp.
Decision Date1986-09-11
Product CodeFQZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEALTHCHECK THERM-STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Healthcheck Corp.. It received FDA 510(k) clearance on 1986-09-11 under 510(k) number K863181. 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 HEALTHCHECK THERM-STRIP?

HEALTHCHECK THERM-STRIP is a medical device that received FDA 510(k) clearance on 1986-09-11. The listed applicant is Healthcheck Corp.. The 510(k) number is K863181.

When did HEALTHCHECK THERM-STRIP receive FDA 510(k) clearance?

HEALTHCHECK THERM-STRIP received FDA 510(k) clearance on 1986-09-11, under 510(k) number K863181.

Who is the listed applicant for HEALTHCHECK THERM-STRIP?

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

What is the FDA product code for HEALTHCHECK THERM-STRIP?

The FDA product code for HEALTHCHECK THERM-STRIP is FQZ.

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Other records listing Healthcheck 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.

K884489C&T PREGNANCY TEST KITK874818TENSTARK881003DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1K861946PTK PLUS. HOME PREGNANCY TESTK860287PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3K851379HEALTHCHECK DIGITAL THERMOMETER MODEL 1 TH-2

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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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