Rune Labs, Inc.
United Statesfrom the FDA registration address FDA FEI 3023231645
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Rune Labs, Inc. makes
Rune Labs, Inc. manufactures the Rune Labs Tremor Transducer System, a device designed to measure and analyze physiological tremors for diagnostic or monitoring purposes.
The company’s product portfolio is regulated under Class II devices in the United States and is listed via FDA 510(k) clearance. The manufacturer is based in the US.
Catalogue
Rune Labs Tremor Transducer System Ref K213519
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3023231645
- Address
- 1314 8th Ave, San Francisco, CA, 94122
Frequently asked questions
How many devices does Rune Labs, Inc. have in the registry?
The registry currently lists 1 device for Rune Labs, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rune Labs, Inc.'s devices?
Among its 1 most recently registered device, Rune Labs, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Rune Labs, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Rune Labs, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Rune Labs, Inc. in the registry?
The most recently registered devices listed for Rune Labs, Inc. include Rune Labs Tremor Transducer System.