Harvey-Bostwick, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Harvey-Bostwick, Inc. makes
Harvey-Bostwick, Inc. manufactures cardiac monitoring devices, including the Apnea/Bradycardia Monitor HB 95 and the Bradycardia Monitor HB85. These devices are designed to detect and alert for abnormal heart rhythms, such as bradycardia (slow heart rate) and apnea-related events, in clinical or patient-monitoring settings.
The company’s portfolio is regulated under Class II medical devices in the United States, with products authorised through the FDA’s 510(k) clearance process. These devices are listed in the FDA’s 510(k) registry, reflecting their compliance with applicable regulatory requirements.
Catalogue
Apnea/Bradycardia Monitor Hb 95 Ref K830666
Regimes: 510(k) Registry: 510(k)Harvey-Bostwick Brady Cardia Monit. HB85 Ref K821942
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Harvey-Bostwick, Inc. have in the registry?
The registry currently lists 2 devices for Harvey-Bostwick, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Harvey-Bostwick, Inc.'s devices?
Among its 2 most recently registered devices, Harvey-Bostwick, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Harvey-Bostwick, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Harvey-Bostwick, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Harvey-Bostwick, Inc. in the registry?
The most recently registered devices listed for Harvey-Bostwick, Inc. include APNEA/BRADYCARDIA MONITOR HB 95 and HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85.