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FDA 510(k)

THERMAL CONDITIONING SYSTEM

K-Number: K791154 · 1979-10-09

ApplicantAcurex Aerotherm
Decision Date1979-10-09
Product CodeIRT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERMAL CONDITIONING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acurex Aerotherm. It received FDA 510(k) clearance on 1979-10-09 under 510(k) number K791154. The device is classified under product code IRT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMAL CONDITIONING SYSTEM?

THERMAL CONDITIONING SYSTEM is a medical device that received FDA 510(k) clearance on 1979-10-09. The listed applicant is Acurex Aerotherm. The 510(k) number is K791154.

When did THERMAL CONDITIONING SYSTEM receive FDA 510(k) clearance?

THERMAL CONDITIONING SYSTEM received FDA 510(k) clearance on 1979-10-09, under 510(k) number K791154.

Who is the listed applicant for THERMAL CONDITIONING SYSTEM?

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

What is the FDA product code for THERMAL CONDITIONING SYSTEM?

The FDA product code for THERMAL CONDITIONING SYSTEM is IRT.

Related Clinical Trials

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Related Devices (Code: IRT)

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.

K250047bite away twomibeTec GmbHK220514bite away neomibeTec GmbHK160943Bite AwayRiemser PharmaK111273FIR HEAT THERAPHY SYSYEMSShenzhen Anpan Technology Co., Ltd.K072534BIO-MAT 2000Richway Intl., Inc.K963887PT-PAC PORTABLE HEATING PADAnthony A. Chiurco

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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