Medical Device Manufacturer · US , Hasbrouck Heights , NJ

Aerotel Medical Systems (1998) , Ltd. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1999

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Aerotel Medical Systems (1998) , Ltd. Cardiovascular ✕

7 devices

1-7 of 7

Cleared Oct 03, 2003

Cardiovascular · 29d

Cleared Mar 28, 2003

Cardiovascular · 14d

Cleared Nov 06, 2002

HEARTONE EVENT RECORDER AND TRANSMITTER

Cardiovascular · 26d

Cleared Jul 24, 2002

HEARTLINE RECEIVING STATION

Cardiovascular · 28d

Cleared May 22, 2002

TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM

Cardiovascular · 16d

Cleared May 17, 2000

Cardiovascular · 69d

Cleared Sep 16, 1999

BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM

Cardiovascular · 330d