Stanza
FDA 510(k) clearance DEN220083 · decided 2023-05-09
Clearance details
- K-number
- DEN220083
- Device name
- Stanza
- Applicant
- Swing Therapeutics, Inc.
- Decision
- Unknown
- Date received
- 2022-11-21
- Decision date
- 2023-05-09
- Days to decision
- 169 days
- Clearance type
- Direct
- Product code
- QWI
- Device class
- 2
- Regulation number
- 882.5804
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.