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FDA 510(k)

ACCA-TEMP SKIN TEMP. VINYL DISC

K-Number: K823221 · 1983-01-12

ApplicantT. G. & E. Medical
Decision Date1983-01-12
Product CodeKPD
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACCA-TEMP SKIN TEMP. VINYL DISC is the device name listed in this FDA 510(k) record. The listed applicant is T. G. & E. Medical. It received FDA 510(k) clearance on 1983-01-12 under 510(k) number K823221. 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 ACCA-TEMP SKIN TEMP. VINYL DISC?

ACCA-TEMP SKIN TEMP. VINYL DISC is a medical device that received FDA 510(k) clearance on 1983-01-12. The listed applicant is T. G. & E. Medical. The 510(k) number is K823221.

When did ACCA-TEMP SKIN TEMP. VINYL DISC receive FDA 510(k) clearance?

ACCA-TEMP SKIN TEMP. VINYL DISC received FDA 510(k) clearance on 1983-01-12, under 510(k) number K823221.

Who is the listed applicant for ACCA-TEMP SKIN TEMP. VINYL DISC?

The FDA 510(k) record lists T. G. & E. Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCA-TEMP SKIN TEMP. VINYL DISC?

The FDA product code for ACCA-TEMP SKIN TEMP. VINYL DISC 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.

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Other records listing T. G. & E. Medical 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.

K860706IV BAND (INTRAVENOUS CATHETER ASSESORY)K860261CANNULA BANDK820941THERMA-SCANK813199SKIN TEMPERATURE SENSING VINYL STRIP

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

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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