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510(k) K961845

PERCUPUMP II WITH EDA by E-Z-Em, Inc. — Product Code DSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1997
Date Received
May 13, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Impedance
Device Class
Class II
Regulation Number
870.2770
Review Panel
CV
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)

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