Medical Device Manufacturer · US , Providence , RI

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

6 submissions · 6 cleared · Since 1995

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Heartlab, Inc. Radiology ✕

5 devices

1-5 of 5

Cleared Feb 18, 2005

AGFA HEARTLAB CARDIOVASCULAR

Radiology · 17d

Cleared Sep 21, 2004

ULTRASOUND CAPTURE SYSTEM

Radiology · 54d

Cleared Jul 16, 2004

MODIFICATION TO ENCOMPASS

Radiology · 101d

Cleared Feb 21, 1996

Radiology · 148d

Cleared Dec 21, 1995

Radiology · 59d