BT-001
FDA 510(k) clearance DEN220058 · decided 2023-07-07
Clearance details
- K-number
- DEN220058
- Device name
- BT-001
- Applicant
- Better Therapeutics
- Decision
- Unknown
- Date received
- 2022-09-21
- Decision date
- 2023-07-07
- Days to decision
- 289 days
- Clearance type
- Direct
- Product code
- QXC
- Device class
- 2
- Regulation number
- 880.5735
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- 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.