Heartstream, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Heartstream, Inc. makes
Heartstream, Inc. manufactures external defibrillator pads with preattached electrode adapters (DP-EAXX series) and standalone external defibrillators (Fore Runner series), including compatible electrode adapters (EA-XX series). These devices are designed for emergency cardiac resuscitation to restore normal heart rhythms in patients experiencing sudden cardiac arrest.
The company’s products are classified as Class III medical devices under US regulations and are listed via FDA 510(k) clearance. The portfolio is authorised for commercial distribution in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Heartstream, Inc. have in the registry?
The registry currently lists 2 devices for Heartstream, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Heartstream, Inc.'s devices?
Among its 2 most recently registered devices, Heartstream, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Heartstream, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Heartstream, Inc.'s devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from Heartstream, Inc. in the registry?
The most recently registered devices listed for Heartstream, Inc. include HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX) and FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS.