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FDA 510(k)

TEMPTREND PEDS AXILLARY TEMP. INDICATOR

K-Number: K841913 · 1984-11-02

ApplicantBiosynergy, Inc.
Decision Date1984-11-02
Product CodeKPD
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TEMPTREND PEDS AXILLARY TEMP. INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Biosynergy, Inc.. It received FDA 510(k) clearance on 1984-11-02 under 510(k) number K841913. The device is classified under product code KPD. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMPTREND PEDS AXILLARY TEMP. INDICATOR?

TEMPTREND PEDS AXILLARY TEMP. INDICATOR is a medical device that received FDA 510(k) clearance on 1984-11-02. The listed applicant is Biosynergy, Inc.. The 510(k) number is K841913.

When did TEMPTREND PEDS AXILLARY TEMP. INDICATOR receive FDA 510(k) clearance?

TEMPTREND PEDS AXILLARY TEMP. INDICATOR received FDA 510(k) clearance on 1984-11-02, under 510(k) number K841913.

Who is the listed applicant for TEMPTREND PEDS AXILLARY TEMP. INDICATOR?

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

What is the FDA product code for TEMPTREND PEDS AXILLARY TEMP. INDICATOR?

The FDA product code for TEMPTREND PEDS AXILLARY TEMP. INDICATOR is KPD.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biosynergy, Inc. 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.

K833904TEMPTREND II

Related Devices (Code: KPD)

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.

K934941E-Z TEMP IISeven C'S, Inc.K903307TEMP MARQ TEMPERATURE TREND INDICATORMarquest Medical Products, Inc.K893803FEVER LINE AND FEVER LINE PLUSLiquid Crystal Sciences, Inc.K864853OMNI THERM TEMPERATURE MONITOROmni Therm, Inc.K850797TEMPALERT LIQUID CRYSTAL THERMOMETERMedical Frontiers, Inc.K833904TEMPTREND IIBiosynergy, Inc.

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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