Bl Healthcare, Inc. is one of 15076 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Bl Healthcare, Inc. - FDA 510(k) Cleared Devices
Recent clearances: TCX-I REMOTE CARE MANAGEMENT SYSTEM, BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM, TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM
5
Total
5
Cleared
0
Denied
Bl Healthcare, Inc. has 5 FDA 510(k) cleared medical devices. Based in Foxboro, US.
Historical record: 5 cleared submissions from 2005 to 2011. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Bl Healthcare, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Tuv Rheinland of North America, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Bl Healthcare, Inc.
5 devices
Cleared
Dec 21, 2011
TCX-I REMOTE CARE MANAGEMENT SYSTEM
Cardiovascular
26d
Cleared
May 10, 2010
BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM
Cardiovascular
21d
Cleared
Feb 09, 2010
TCX-I-DV REMOTE CARE MANAGEMENT SYSTEM
Gastroenterology & Urology
103d
Cleared
Feb 01, 2006
TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS)
Cardiovascular
132d
Cleared
Jun 08, 2005
REMOTE CARE MANAGEMENT SYSTEMS (RCMS)
Cardiovascular
5d