Sulzer Oscor, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Sulzer Oscor, Inc. makes
Sulzer Oscor, Inc. manufactures cardiac pacemaker systems, including the PACE 101H model, which is designed for temporary pacing applications, and the HT series (e.g., HT PB), intended for hemodynamic monitoring and temporary pacing in critical care settings.
The company’s portfolio includes devices classified as Class II and Class III under FDA regulations, with products authorised through the 510(k) pathway. These devices are listed in the FDA’s 510(k) clearance registry, and the manufacturer operates from the United States.
Catalogue
Pace 101H Ref K970497
Regimes: 510(k) Registry: 510(k)Ht, Model Ht Pb Ref K990142
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sulzer Oscor, Inc. have in the registry?
The registry currently lists 2 devices for Sulzer Oscor, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sulzer Oscor, Inc.'s devices?
Among its 2 most recently registered devices, Sulzer Oscor, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Sulzer Oscor, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sulzer Oscor, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Sulzer Oscor, Inc. in the registry?
The most recently registered devices listed for Sulzer Oscor, Inc. include PACE 101H and HT, MODEL HT PB.