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FDA 510(k)

PARATHERM

K-Number: K821049 · 1982-04-29

ApplicantAmerican Thermometer Company, Inc.
Decision Date1982-04-29
Product CodeKYA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PARATHERM is the device name listed in this FDA 510(k) record. The listed applicant is American Thermometer Company, Inc.. It received FDA 510(k) clearance on 1982-04-29 under 510(k) number K821049. The device is classified under product code KYA. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARATHERM?

PARATHERM is a medical device that received FDA 510(k) clearance on 1982-04-29. The listed applicant is American Thermometer Company, Inc.. The 510(k) number is K821049.

When did PARATHERM receive FDA 510(k) clearance?

PARATHERM received FDA 510(k) clearance on 1982-04-29, under 510(k) number K821049.

Who is the listed applicant for PARATHERM?

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

What is the FDA product code for PARATHERM?

The FDA product code for PARATHERM is KYA.

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 American Thermometer Company, 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.

K823245THERMAX; THERMAX SYSTEMK771980FEVER TESTER

Related Devices (Code: KYA)

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.

K900404VARICOSCREEN(TM)Promedex, Inc.K832989BREAST THERMAL ACTIVITY INDICATORBcsi Laboratories, Inc.K823245THERMAX; THERMAX SYSTEMAmerican Thermometer Company, Inc.K821524CHIROPRATIC INFRA-RED CRYSTAL PAKDr. John D. Reid B.A., D.C.

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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