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510(k) K913226

MODEL #810 STEALTH-STIM ADULT STIMULATION PADS by Cardiotronics, Inc. — Product Code DRX

K913226 is an FDA 510(k) premarket notification submitted by Cardiotronics, Inc. for the device "MODEL #810 STEALTH-STIM ADULT STIMULATION PADS". The FDA issued a decision of Substantially Equivalent on September 4, 1991. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Cardiotronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1991
Date Received
July 19, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrocardiograph
Device Class
Class II
Regulation Number
870.2360
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)
  • K922173 — MODEL # 830 ST ADULT STIMULATION PADS (STERILE) (June 11, 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)
  • 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)
  • K912621 — MODEL #911 STEALTH MULTI PADS (October 16, 1991)

Other clearances for product code DRX

  • K171244 — Physiotrace (August 23, 2017)
  • K140096 — HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE (July 24, 2014)
  • K123658 — BIOMODULE 3-M1 (April 24, 2013)
  • K101576 — CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES (July 22, 2010)
  • K101685 — IP-SET (July 1, 2010)
  • K100129 — AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X (June 11, 2010)
  • K093327 — INTCO TAB ELECTRODE (May 10, 2010)
  • K100315 — 12 LEAD GLOVE (April 23, 2010)
  • K092744 — NEONATAL ECG ELECTRODE, M203KEN (December 10, 2009)
  • K092389 — DISPOSAL ECG ELECTRODES, MODEL EASYRODE (October 13, 2009)

FDA data resources