Pearl Instruments Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Pearl Instruments Corp. makes
Pearl Instruments Corp. manufactures the BT-1 Fot Bolt Installation Kit, used for securing intracranial pressure monitoring devices, and the FT-100 Intracranial Pressure Monitor, which measures cerebrospinal fluid pressure in clinical settings.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) clearance process. Pearl Instruments Corp. is based in the United States.
Catalogue
Model Bt-1 Fot Bolt Installation Kit Ref K896834
Regimes: 510(k) Registry: 510(k)Model Ft-100 Intracranial Pressure Monitor Ref K890468
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pearl Instruments Corp. have in the registry?
The registry currently lists 2 devices for Pearl Instruments Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pearl Instruments Corp.'s devices?
Among its 2 most recently registered devices, Pearl Instruments Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Pearl Instruments Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Pearl Instruments Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pearl Instruments Corp. in the registry?
The most recently registered devices listed for Pearl Instruments Corp. include MODEL BT-1 FOT BOLT INSTALLATION KIT and MODEL FT-100 INTRACRANIAL PRESSURE MONITOR.