Medical Device Manufacturer · US , Tustin , CA

Diagnostic Monitoring Software - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1992

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Diagnostic Monitoring Software Cardiovascular ✕

5 devices

1-5 of 5

Cleared May 19, 2014

DMS 300-2W HOLTER ECG RECORDER

Cardiovascular · 236d

Cleared Oct 16, 2006

DMS 300-2, 300-3 AND 300-4

Cardiovascular · 17d

Cleared Aug 25, 2006

PREMIER 11 HOLTER

Cardiovascular · 32d

Cleared Aug 16, 2006

Cardiovascular · 30d

Cleared Jan 08, 1992

HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300

Cardiovascular · 272d