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FDA 510(k)

TEMPTREND II

K-Number: K833904 · 1983-12-27

ApplicantBiosynergy, Inc.
Decision Date1983-12-27
Product CodeKPD
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TEMPTREND II is the device name listed in this FDA 510(k) record. The listed applicant is Biosynergy, Inc.. It received FDA 510(k) clearance on 1983-12-27 under 510(k) number K833904. 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 II?

TEMPTREND II is a medical device that received FDA 510(k) clearance on 1983-12-27. The listed applicant is Biosynergy, Inc.. The 510(k) number is K833904.

When did TEMPTREND II receive FDA 510(k) clearance?

TEMPTREND II received FDA 510(k) clearance on 1983-12-27, under 510(k) number K833904.

Who is the listed applicant for TEMPTREND II?

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 II?

The FDA product code for TEMPTREND II 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.

K841913TEMPTREND PEDS AXILLARY TEMP. INDICATOR

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.K841913TEMPTREND PEDS AXILLARY TEMP. INDICATORBiosynergy, 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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