Medical Device Manufacturer · US , Cambridge , MA

Zmi Corp. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1986

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Zmi Corp. Cardiovascular ✕

7 devices

1-7 of 7

Cleared Feb 07, 1992

PEDIATRIC MULTI-FUNCTION ELECTRODES

Cardiovascular · 85d

Cleared Dec 16, 1991

ZOLL D-900 DEFIBRILLATOR

Cardiovascular · 132d

Cleared Jul 31, 1991

ZOLL PD-1400 PACER/DEFIBRILLATOR

Cardiovascular · 90d

Cleared Oct 12, 1989

ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES

Cardiovascular · 65d

Cleared May 01, 1989

ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES

Cardiovascular · 139d

Cleared Nov 23, 1987

ZOLL NTP-1200 PACER/DEFIBRILLATOR

Cardiovascular · 91d

Cleared Mar 31, 1986

NONINVASIVE TEMP. PACEMAKER NTP-1000

Cardiovascular · 105d