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510(k) K770986

FLEXI-THERM FILM by E-Z-Em, Inc. — Product Code KXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1977
Date Received
May 31, 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

Other clearances by E-Z-Em, Inc.

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  • K063029 — EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 (November 2, 2006)
  • K053008 — E-Z-EM ENDOSCOPIC CO2 REGULATOR (December 27, 2005)
  • K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725) (July 16, 2004)
  • K031571 — EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 (June 19, 2003)
  • K030854 — PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 (April 16, 2003)
  • K013219 — PROTOCO2L INSUFFLATOR MODEL 6400 (February 19, 2002)
  • K011160 — E-Z EM PERCUPUMP 2001 CT INJECTOR (May 16, 2001)
  • K974621 — PERCUPUMP II WITH EDA (January 27, 1998)

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)
  • K770678 — ELC-THERMO-SYSTEM (May 25, 1977)