Medical Device Manufacturer · US , Houston , TX

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

2 submissions · 2 cleared · Since 1986

Recent clearances: CARTOUCH, SPECTRUM POLYCORD I RECORDER SYSTEM

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

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

2 devices

1-2 of 2

Cleared Dec 27, 2000

Cardiovascular · 160d

Cleared Aug 18, 1986

SPECTRUM POLYCORD I RECORDER SYSTEM

Cardiovascular · 27d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Oct 06, 2026