Medical Device Manufacturer · IL , Israel

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

6 submissions · 6 cleared · Since 1994

6

Total

6

Cleared

0

Denied

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

6 devices

1-6 of 6

Cleared Jun 16, 1998

HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER

Cardiovascular · 152d

Cleared Jul 18, 1996

HEART 400 ECG TRANSMITTER

Cardiovascular · 342d

Cleared Jul 10, 1996

AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE

Cardiovascular · 92d

Cleared Oct 24, 1995

HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER

Cardiovascular · 294d

Cleared Jan 11, 1995

Cardiovascular · 684d

Cleared Mar 18, 1994

HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE

Cardiovascular · 420d