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510(k) K813547

THERMASCAN by Bcd Products, Inc. — Product Code KXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1982
Date Received
December 21, 1981
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 Bcd Products, Inc.

  • K831773 — MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK (August 16, 1983)

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  • K832731 — BREAST & BODY HEALTH SYSTEM 2000 (January 30, 1984)
  • K781916 — FLEXT-THERM (February 2, 1979)
  • K770986 — FLEXI-THERM FILM (September 12, 1977)
  • K770678 — ELC-THERMO-SYSTEM (May 25, 1977)