Medical Device Manufacturer · US , Tualatin , OR

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

10 submissions · 10 cleared · Since 1987

10

Total

10

Cleared

0

Denied

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

10 devices

1-10 of 10

Cleared Mar 07, 1988

MONITOR, ELECTROGRAPHIC

Cardiovascular · 138d

Cleared Jan 27, 1988

DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC

Cardiovascular · 91d

Cleared Dec 15, 1987

300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER

Cardiovascular · 69d

Cleared Nov 23, 1987

360D DC DEFIBRILLATOR

Cardiovascular · 47d

Cleared Apr 23, 1987

PACE 10 NON-INVASIVE EXTERNAL PACEMAKER

Cardiovascular · 30d

Cleared Mar 10, 1987

DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE

Cardiovascular · 78d

Cleared Mar 03, 1987

ETP 300 NON-INVASIVE EXTERNAL PACEMAKER

Cardiovascular · 71d

Cleared Mar 03, 1987

DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE

Cardiovascular · 71d

Cleared Mar 03, 1987

ETP 180E NON-INVASIVE EXTERNAL PACEMAKER

Cardiovascular · 71d

Cleared Mar 03, 1987

ETP 180A NON-INVASIVE EXTERNAL PACEMAKER

Cardiovascular · 71d