Medical Device Manufacturer · US , Millburn , NJ

Paceart, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1987

Recent clearances: PACEART TX3 CARDIAC EVENT RECORDER, PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM, HEART ACCESS PLUS CARDIAC EVENT RECORDER

View 9 510(k) Devices ↓

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Paceart, Inc. Cardiovascular ✕

9 devices

1-9 of 9

Cleared Aug 14, 2001

PACEART TX3 CARDIAC EVENT RECORDER

Cardiovascular · 15d

Cleared Jan 26, 1999

PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM

Cardiovascular · 225d

Cleared Nov 12, 1997

HEART ACCESS PLUS CARDIAC EVENT RECORDER

Cardiovascular · 83d

Cleared Jul 18, 1996

PACEART WRIST ELECTRODES

Cardiovascular · 147d

Cleared Jan 16, 1996

PACEART CARDIOVOICE

Cardiovascular · 259d

Cleared Oct 01, 1993

PACEART CARDIOPHONE

Cardiovascular · 185d

Cleared Apr 14, 1992

PACEART CPTS-86/12

Cardiovascular · 119d

Cleared Mar 09, 1988

PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS

Cardiovascular · 47d

Cleared Apr 27, 1987

PACEMAKER FUNCTION ANALYZER

Cardiovascular · 53d