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510(k) K770678

ELC-THERMO-SYSTEM by Cutter Laboratories, Inc. — Product Code KXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1977
Date Received
April 11, 1977
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

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  • K802104 — C-SPLINT (September 16, 1980)
  • K802105 — C-BLADE (September 16, 1980)

Other clearances for product code KXZ

  • K851034 — NOVATHERM (September 27, 1985)
  • K843124 — Q-SCAN THERMOGRAPHY SYSTEM (November 29, 1984)
  • K832731 — BREAST & BODY HEALTH SYSTEM 2000 (January 30, 1984)
  • K813547 — THERMASCAN (March 12, 1982)
  • K781916 — FLEXT-THERM (February 2, 1979)
  • K770986 — FLEXI-THERM FILM (September 12, 1977)