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FDA 510(k)

SAPCRILL THERMODETECT BREAST SCANNER DEV

K-Number: K801573 · 1980-09-09

ApplicantCalifornia Cardiac Systems, Inc.
Decision Date1980-09-09
Product CodeKYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAPCRILL THERMODETECT BREAST SCANNER DEV is the device name listed in this FDA 510(k) record. The listed applicant is California Cardiac Systems, Inc.. It received FDA 510(k) clearance on 1980-09-09 under 510(k) number K801573. The device is classified under product code KYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAPCRILL THERMODETECT BREAST SCANNER DEV?

SAPCRILL THERMODETECT BREAST SCANNER DEV is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is California Cardiac Systems, Inc.. The 510(k) number is K801573.

When did SAPCRILL THERMODETECT BREAST SCANNER DEV receive FDA 510(k) clearance?

SAPCRILL THERMODETECT BREAST SCANNER DEV received FDA 510(k) clearance on 1980-09-09, under 510(k) number K801573.

Who is the listed applicant for SAPCRILL THERMODETECT BREAST SCANNER DEV?

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

What is the FDA product code for SAPCRILL THERMODETECT BREAST SCANNER DEV?

The FDA product code for SAPCRILL THERMODETECT BREAST SCANNER DEV is KYZ.

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Related Devices (Code: KYZ)

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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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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