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510(k) K922064

MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE by Cardiotronics, Inc. — Product Code GXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1992
Date Received
May 4, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Lesion, Radiofrequency
Device Class
Class II
Regulation Number
882.4400
Review Panel
NE
Submission Type

Other clearances by Cardiotronics, Inc.

  • K932903 — EKG VEST (February 24, 1995)
  • 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)
  • K911456 — MODEL #110 STEALTH-TRODE CHILD DEFIB PADS (October 16, 1991)
  • K912621 — MODEL #911 STEALTH MULTI PADS (October 16, 1991)

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