Topera, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Topera, Inc. makes
Topera, Inc. manufactures electrophysiological (EP) mapping systems, including the RHYTHM VIEW software and FIRMAP catheter for cardiac electroanatomical mapping. The company also produces the Rhythm View Workstation, available in both non-streaming and streaming configurations, along with the FRIMAP ADAPTER CONNECTOR for MAC systems. These tools are designed for intracardiac electrogram acquisition and visualization during cardiac procedures.
The company’s products fall under FDA Class II devices and are listed via the 510(k) clearance pathway. Topera, Inc. is based in the United States. No additional regulatory registries are specified for these devices.
Catalogue
Rhythm View Ref K123295
Regimes: 510(k) Registry: 510(k)Firmap Catheter Ref K130827
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frimap Adapter Connector (Mac) Ref K142182
Regimes: 510(k) Registry: 510(k)RhythmView Workstation Ref K142901
Regimes: 510(k) Registry: 510(k)Rhythmview (Tm) Ref K110878
Regimes: 510(k) Registry: 510(k)Rhythm View Workstation Ref K133305
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Topera, Inc. have in the registry?
The registry currently lists 7 devices for Topera, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Topera, Inc.'s devices?
Among its 7 most recently registered devices, Topera, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Topera, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Topera, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Topera, Inc. in the registry?
The most recently registered devices listed for Topera, Inc. include RHYTHM VIEW, FIRMAP CATHETER, Rhythm View Workstation (non-streaming, steaming option) and FRIMAP ADAPTER CONNECTOR (MAC).