SAPCRILL THERMODETECT BREAST SCANNER DEV— 510(k) K801573

Substantially Equivalent

California Cardiac Systems, Inc.

FDA 510(k) clearance K801573 for SAPCRILL THERMODETECT BREAST SCANNER DEV, Substantially Equivalent on 1980-09-09. Applicant: California Cardiac Systems, Inc.. Device class: 1.

Clearance details

Applicant
California Cardiac Systems, Inc.
Product code
Code KYZ
Device class
Class 1
Regulation
21 CFR 880.6960
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
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