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510(k) K960721

PACEART WRIST ELECTRODES by Paceart, Inc. — Product Code DRX

K960721 is an FDA 510(k) premarket notification submitted by Paceart, Inc. for the device "PACEART WRIST ELECTRODES". The FDA issued a decision of Substantially Equivalent on July 18, 1996. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Paceart, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1996
Date Received
February 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 Paceart, Inc.

  • K012407 — PACEART TX3 CARDIAC EVENT RECORDER (August 14, 2001)
  • K982090 — PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM (January 26, 1999)
  • K973141 — HEART ACCESS PLUS CARDIAC EVENT RECORDER (November 12, 1997)
  • K952065 — PACEART CARDIOVOICE (January 16, 1996)
  • K931296 — PACEART CARDIOPHONE (October 1, 1993)
  • K915632 — PACEART CPTS-86/12 (April 14, 1992)
  • K880283 — PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS (March 9, 1988)
  • K870909 — PACEMAKER FUNCTION ANALYZER (April 27, 1987)

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