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510(k) K935429

ARBO H90, H91, H135 DISPOSABLE MONITORING ELECTRODES by Arbo Medical, Inc. — Product Code DRX

K935429 is an FDA 510(k) premarket notification submitted by Arbo Medical, Inc. for the device "ARBO H90, H91, H135 DISPOSABLE MONITORING ELECTRODES". The FDA issued a decision of Substantially Equivalent on November 1, 1994. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Arbo Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1994
Date Received
November 10, 1993
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 Arbo Medical, Inc.

  • K940323 — ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & (April 12, 1995)
  • K935437 — ARBO H85V/H87V/H27V DISPOS MONIT ELECTRODES (April 6, 1995)
  • K942905 — DISPOSABLE TEMPERATURE PROBE COVER (February 27, 1995)
  • K940302 — ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE & L (November 30, 1994)
  • K940322 — ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY CABLE & LEAD WIRE (November 28, 1994)
  • K935246 — ARBO H49P, H59P DISPOSABLE MONITORING ELECTRODES (November 16, 1994)
  • K935281 — ARBO H87P, H85P, H27P DISPOSABLE MONITORING ELECTRODES (September 6, 1994)
  • K905545 — ULTRASOUND TRANSMISSION GEL (March 29, 1991)
  • K902788 — CLEM TM (September 12, 1990)
  • K901816 — PRESSURE TUBING AND ACCESSORIES (July 12, 1990)

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