Positron Corp.
United StatesFDA applicant, unverified
- Devices
- 5
What Positron Corp. makes
Positron Corp. manufactures the MPOWER Model 712 series, a medical device intended for clinical use. The product is classified as a Class II device.
The MPOWER Model 712 series is listed in the FDA 510(k) database, indicating it is subject to U.S. FDA regulatory requirements for Class II devices. Positron Corp. is based in the United States.
Catalogue
Automatic Screening Audiometer Ref K810537
Regimes: 510(k) Registry: 510(k)Posicam-Hz & Posicam-Hzl Ref K926206
Regimes: 510(k) Registry: 510(k)Posicam System Model 6.5 Posicam-Hz System Ref K911275
Regimes: 510(k) Registry: 510(k)Modified Posicam System Model 6.5 Ref K894998
Regimes: 510(k) Registry: 510(k)Mpower, Model 712 Series Ref K022001
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Positron Corp. have in the registry?
The registry currently lists 5 devices for Positron Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Positron Corp.'s devices?
Among its 5 most recently registered devices, Positron Corp. has devices listed in FDA 510(k) (5 devices).
What risk classes do Positron Corp.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Positron Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Positron Corp. in the registry?
The most recently registered devices listed for Positron Corp. include AUTOMATIC SCREENING AUDIOMETER, POSICAM-HZ & POSICAM-HZL, POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM and MODIFIED POSICAM SYSTEM MODEL 6.5.