Medical Device Manufacturer · US , Eden Prairie , MN

American Telecare, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1995

9

Total

9

Cleared

0

Denied

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

9 devices

1-9 of 9

Cleared Aug 19, 2003

Cardiovascular · 209d

Cleared Jun 28, 2001

AVIVA SYSTEM, MODEL SL 2020

Cardiovascular · 184d

Cleared Jan 13, 2000

AVIVA SYSTEM, MODEL SL1010

Cardiovascular · 85d

Cleared Jul 15, 1998

AVIVA SYSTEMS MODEL NUMBERS 1010, 2020

Cardiovascular · 77d

Cleared Dec 29, 1997

DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1

Cardiovascular · 80d

Cleared Feb 24, 1997

Cardiovascular · 164d

Cleared Dec 17, 1996

PERSONAL TELEMEDICINE MODULE

Cardiovascular · 34d

Cleared Sep 09, 1996

PERSONAL TELEMEDICINE SYSTEM

Cardiovascular · 444d

Cleared May 17, 1995

TELPHONIC STETHOSCOPE

Cardiovascular · 182d