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FDA 510(k)

BREAST THERMAL ACTIVITY INDICATOR

K-Number: K832989 · 1984-01-17

ApplicantBcsi Laboratories, Inc.
Decision Date1984-01-17
Product CodeKYA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BREAST THERMAL ACTIVITY INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Bcsi Laboratories, Inc.. It received FDA 510(k) clearance on 1984-01-17 under 510(k) number K832989. 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 BREAST THERMAL ACTIVITY INDICATOR?

BREAST THERMAL ACTIVITY INDICATOR is a medical device that received FDA 510(k) clearance on 1984-01-17. The listed applicant is Bcsi Laboratories, Inc.. The 510(k) number is K832989.

When did BREAST THERMAL ACTIVITY INDICATOR receive FDA 510(k) clearance?

BREAST THERMAL ACTIVITY INDICATOR received FDA 510(k) clearance on 1984-01-17, under 510(k) number K832989.

Who is the listed applicant for BREAST THERMAL ACTIVITY INDICATOR?

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

What is the FDA product code for BREAST THERMAL ACTIVITY INDICATOR?

The FDA product code for BREAST THERMAL ACTIVITY INDICATOR is KYA.

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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.K823245THERMAX; THERMAX SYSTEMAmerican Thermometer Company, 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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