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510(k) K832731

BREAST & BODY HEALTH SYSTEM 2000 by American Thermal Instruments, Inc. — Product Code KXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1984
Date Received
August 4, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by American Thermal Instruments, Inc.

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  • K781916 — FLEXT-THERM (February 2, 1979)
  • K770986 — FLEXI-THERM FILM (September 12, 1977)
  • K770678 — ELC-THERMO-SYSTEM (May 25, 1977)