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510(k) K911402

MODEL #350 SHOCK-PLATE DEFIB ADAPTOR by Cardiotronics, Inc. — Product Code LDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1991
Date Received
March 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Device Class
Class II
Regulation Number
870.5300
Review Panel
CV
Submission Type

Other clearances by Cardiotronics, Inc.

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  • K922172 — MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE) (June 11, 1992)
  • K922227 — MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE (June 11, 1992)
  • K922173 — MODEL # 830 ST ADULT STIMULATION PADS (STERILE) (June 11, 1992)
  • K921606 — MODEL #125 CHILD STIMULATION PADS (May 26, 1992)
  • K920086 — SHOCK-PATCH ADULT DEFIBRILLATION PADS (February 3, 1992)
  • K914725 — COORDINATOR, CABLE INPUT (November 5, 1991)
  • K911455 — MODEL #100 SHOCK-TRODE CHILD DEFIB PADS (October 16, 1991)

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  • K103334 — CARDIO MED (January 18, 2011)
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  • K102468 — ZOLL PROPAQ MD (September 30, 2010)