Precitron A.B.
SwedenFDA applicant, unverified
- Devices
- 1
What Precitron A.B. makes
Precitron A.B. manufactures the APOLLO 5 and APOLLO 10, which are medical devices designed for specific diagnostic or therapeutic procedures within their intended classifications.
These devices are classified as Class II under US regulations and are listed via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Apollo 5, Apollo 10 Ref K990383
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Precitron A.B. have in the registry?
The registry currently lists 1 device for Precitron A.B.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Precitron A.B.'s devices?
Among its 1 most recently registered device, Precitron A.B. has devices listed in FDA 510(k) (1 device).
What risk classes do Precitron A.B.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Precitron A.B.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Precitron A.B. in the registry?
The most recently registered devices listed for Precitron A.B. include APOLLO 5, APOLLO 10.