Medical Device Manufacturer · US , Clearwater , FL

Pace Tech, Inc. - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 1988

18

Total

18

Cleared

0

Denied

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

9 devices

1-9 of 9

Cleared Nov 21, 1996

VITALMAX 4000/MINIPACK 3100/3000

Cardiovascular · 612d

Cleared Jan 31, 1995

VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300

Cardiovascular · 89d

Cleared Aug 10, 1994

MINIPACK 3100/3000 MODIFICATION

Cardiovascular · 335d

Cleared Jul 19, 1994

Cardiovascular · 365d

Cleared Feb 03, 1992

MINI-PACK 911 SERIES

Cardiovascular · 222d

Cleared Oct 10, 1991

VITALMAX 830 SERIES

Cardiovascular · 79d

Cleared Jul 17, 1991

VITALMAX 2100/2200

Cardiovascular · 244d

Cleared Jul 18, 1990

VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE

Cardiovascular · 169d

Cleared Mar 22, 1988

Cardiovascular · 56d