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510(k) K912621

MODEL #911 STEALTH MULTI PADS by Cardiotronics, Inc. — Product Code LDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1991
Date Received
June 13, 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.

  • K932903 — EKG VEST (February 24, 1995)
  • K922064 — MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE (December 1, 1992)
  • K923297 — MODEL #340 STEALTH-TRODE+LS (September 18, 1992)
  • 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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  • K102468 — ZOLL PROPAQ MD (September 30, 2010)