Rune Labs Tremor Transducer System— 510(k) K213519
Substantially EquivalentRune Labs, Inc.
FDA 510(k) clearance K213519 for Rune Labs Tremor Transducer System, Substantially Equivalent on 2022-06-10. Applicant: Rune Labs, Inc.. Device class: 2.
Clearance details
- Applicant
- Rune Labs, Inc.
- Product code
- Code GYD
- Device class
- Class 2
- Regulation
- 21 CFR 882.1950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Francisco, CA, US
Recent devices under product code GYD
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