The following data is part of a premarket notification filed by Rune Labs, Inc. with the FDA for Rune Labs Tremor Transducer System.
| Device ID | K213519 |
| 510k Number | K213519 |
| Device Name: | Rune Labs Tremor Transducer System |
| Classification | Transducer, Tremor |
| Applicant | Rune Labs, Inc. 649 Iriving Street San Francisco, CA 94122 |
| Contact | Brian Pepin |
| Correspondent | Courtney Lane Anacapa Clinical Research Inc. 2421 Sunset Dr. Ventura, CA 93001 |
| Product Code | GYD |
| Subsequent Product Code | ISD |
| Subsequent Product Code | NXQ |
| CFR Regulation Number | 882.1950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-03 |
| Decision Date | 2022-06-10 |