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510(k) K832989

BREAST THERMAL ACTIVITY INDICATOR by Bcsi Laboratories, Inc. — Product Code KYA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 17, 1984
Date Received: September 1, 1983
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)
Device Class: Class I
Regulation Number: 884.2982
Review Panel: RA
Submission Type