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FDA 510(k)

THERMAX; THERMAX SYSTEM

K-Number: K823245 · 1982-11-16

ApplicantAmerican Thermometer Company, Inc.
Decision Date1982-11-16
Product CodeKYA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

THERMAX; THERMAX SYSTEM 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 1982-11-16 under 510(k) number K823245. 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 THERMAX; THERMAX SYSTEM?

THERMAX; THERMAX SYSTEM is a medical device that received FDA 510(k) clearance on 1982-11-16. The listed applicant is American Thermometer Company, Inc.. The 510(k) number is K823245.

When did THERMAX; THERMAX SYSTEM receive FDA 510(k) clearance?

THERMAX; THERMAX SYSTEM received FDA 510(k) clearance on 1982-11-16, under 510(k) number K823245.

Who is the listed applicant for THERMAX; THERMAX SYSTEM?

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 THERMAX; THERMAX SYSTEM?

The FDA product code for THERMAX; THERMAX SYSTEM 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.

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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.

K821049PARATHERMK771980FEVER 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.K821524CHIROPRATIC INFRA-RED CRYSTAL PAKDr. John D. Reid B.A., D.C.K821049PARATHERMAmerican Thermometer Company, 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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