Medical Device Manufacturer · US , Northborough , MA

Cardiodata Corp. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1986

4

Total

4

Cleared

0

Denied

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

4 devices

1-4 of 4

Cleared Oct 16, 1990

MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11

Cardiovascular · 250d

Cleared Sep 20, 1988

Cardiovascular · 165d

Cleared Oct 09, 1987

MODEL SSR1 HOLTER MONITOR

Cardiovascular · 51d

Cleared Mar 31, 1986

PRODIGY AND PRODIGY PLUS

Cardiovascular · 73d

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: Apr 27, 2026