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510(k) K871325

BOWEN REUSEABLE/DISPOSABLE ELECTRODE by Bowen & Company, Inc. — Product Code DRX

K871325 is an FDA 510(k) premarket notification submitted by Bowen & Company, Inc. for the device "BOWEN REUSEABLE/DISPOSABLE ELECTRODE". The FDA issued a decision of Substantially Equivalent on June 8, 1987. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Bowen & Company, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1987
Date Received
April 3, 1987
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 Bowen & Company, Inc.

  • K896898 — BOWEN ELECTRODE SKIN PREPATORY CLEANSER (April 4, 1990)
  • K896538 — DISPOSABLE 45 DEGREE SHAVER (December 6, 1989)
  • K873766 — STERNAL POWER AWL (November 14, 1988)
  • K872098 — CREMEEN ALVEOLAR BONE CALIPER (July 31, 1987)
  • K870881 — LOOSE BODY GRASPERS (March 23, 1987)
  • K870882 — 45 DEGREE SHAVER (March 23, 1987)
  • K863147 — GLENOID DRILL (September 5, 1986)
  • K863148 — BOWEN KNOT PASSER (September 5, 1986)
  • K863149 — BOWEN PROBE (September 5, 1986)
  • K863146 — BOWEN SUTURE PASSER (September 5, 1986)

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