Medical Device Manufacturer · US , Millburn , NJ

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

9 submissions · 9 cleared · Since 1987

Total

Cleared

Denied

Paceart, Inc. has 9 FDA 510(k) cleared medical devices. Based in Millburn, US.

Historical record: 9 cleared submissions from 1987 to 2001. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Paceart, Inc. Filter by specialty or product code using the sidebar.

Paceart, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

9 devices

1-9 of 9

Cleared Aug 14, 2001

PACEART TX3 CARDIAC EVENT RECORDER

K012407 · DXH

Cardiovascular · 15d

Cleared Jan 26, 1999

PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM

K982090 · DXH

Cardiovascular · 225d

Cleared Nov 12, 1997

HEART ACCESS PLUS CARDIAC EVENT RECORDER

K973141 · DXH

Cardiovascular · 83d

Cleared Jul 18, 1996

PACEART WRIST ELECTRODES

K960721 · DRX

Cardiovascular · 147d

Cleared Jan 16, 1996

PACEART CARDIOVOICE

K952065 · DXH

Cardiovascular · 259d

Cleared Oct 01, 1993

PACEART CARDIOPHONE

K931296 · DXH

Cardiovascular · 185d

Cleared Apr 14, 1992

PACEART CPTS-86/12

K915632 · KRE

Cardiovascular · 119d

Cleared Mar 09, 1988

PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS

K880283 · DXH

Cardiovascular · 47d

Cleared Apr 27, 1987

PACEMAKER FUNCTION ANALYZER

K870909 · KRE

Cardiovascular · 53d

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

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

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