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510(k) K964213

TRACE RITE SOLID GEL ECG ELECTRODES by Bio-Detek, Inc. — Product Code DRX

K964213 is an FDA 510(k) premarket notification submitted by Bio-Detek, Inc. for the device "TRACE RITE SOLID GEL ECG ELECTRODES". The FDA issued a decision of Substantially Equivalent on November 25, 1996. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Bio-Detek, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1996
Date Received
October 22, 1996
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 Bio-Detek, Inc.

  • K150055 — OneStep Pediatric CPR Multi-Function Electrode (May 2, 2015)
  • K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (May 2, 2015)
  • K133441 — ONESTEP CPR II MULTI-FUNCTION ELECTRODE (October 10, 2014)
  • K100565 — DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0 (November 16, 2010)
  • K071321 — POCKETCPR (September 12, 2007)
  • K040256 — PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005 (April 9, 2004)
  • K040056 — BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 (April 9, 2004)
  • K033771 — BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR (February 27, 2004)
  • K984582 — ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX (March 16, 1999)
  • K990106 — ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES (February 26, 1999)

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