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510(k) K020003

ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE by Bio Protech, Inc. — Product Code DRX

K020003 is an FDA 510(k) premarket notification submitted by Bio Protech, Inc. for the device "ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE". The FDA issued a decision of Substantially Equivalent on November 7, 2002. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Bio Protech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2002
Date Received
January 2, 2002
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 Protech, Inc.

  • K192035 — EvaQMax Smoke Evacuation System (August 29, 2019)
  • K152984 — Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, (June 3, 2016)
  • K153019 — Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes (March 21, 2016)
  • K143103 — PROPENCIL Smoke Pencil (July 16, 2015)
  • K142099 — CUTANEOUS ELECTRODES (November 17, 2014)
  • K111270 — REUSABLE STIMULATING ELECTRODES (September 13, 2011)
  • K100246 — MAX-IF1000 (November 24, 2010)
  • K091248 — MAXEMS, MODELS 1000 AND 2000 (November 30, 2009)
  • K092732 — PROPENCIL ESU PENCIL (November 25, 2009)
  • K092761 — PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C (November 24, 2009)

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