SKEEPER— 510(k) K230613
Substantially EquivalentSmartsound Corporation
FDA 510(k) clearance K230613 for SKEEPER, Substantially Equivalent on 2023-08-02. Applicant: Smartsound Corporation. Device class: 2.
Clearance details
- Applicant
- Smartsound Corporation
- Product code
- Code DQD
- Device class
- Class 2
- Regulation
- 21 CFR 870.1875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
Recent devices under product code DQD
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