Cambridge Heart, Inc.
United StatesFDA applicant, unverified
- Devices
- 17
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Cambridge Heart, Inc. makes
Cambridge Heart, Inc. makes cardiac diagnostic systems, including the CH 2000 and Heartwave Alternans Processing System, as well as sensors like the Micro-V Alternans Sensor. These devices are used for stress testing and alternans processing. The company's products include various models of the CH 2000 Cardiac Diagnostic System and the Heartwave Alternans Processing System.
The company's portfolio is regulated as Class II devices and is listed in the FDA 510(k) registry. Cambridge Heart, Inc. is based in the US.
Catalogue
Search and filter all 17 devicesFDA recalls
FDA recall records list 1 recall initiated by Cambridge Heart, Inc., initiated on 2010-04-29. By recorded status: 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2010
- 29 Apr 2010 Z-1776-2010 Unclassified (pre-2012) Terminated Some kits contained a component with expiration date prior to the date of expiry on the outside of the kit. The user receives feedback of potential unreliable results at several stages during the test process, so any risk of unreliable results is low.
Frequently asked questions
How many devices does Cambridge Heart, Inc. have in the registry?
The registry currently lists 17 devices for Cambridge Heart, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cambridge Heart, Inc.'s devices?
Among its 17 most recently registered devices, Cambridge Heart, Inc. has devices listed in FDA 510(k) (17 devices).
What risk classes do Cambridge Heart, Inc.'s devices fall under?
Among its 17 most recently registered devices, the classes recorded for Cambridge Heart, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Cambridge Heart, Inc.?
FDA recall records list 1 recall initiated by Cambridge Heart, Inc., the most recent initiated on 29 Apr 2010. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Cambridge Heart, Inc. in the registry?
The most recently registered devices listed for Cambridge Heart, Inc. include HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS, CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM and CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000.