Daylight
FDA 510(k) clearance K233872 · decided 2024-08-30
Clearance details
- K-number
- K233872
- Device name
- Daylight
- Applicant
- Big Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-12-07
- Decision date
- 2024-08-30
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- SCP
- Device class
- 2
- Regulation number
- 882.5801
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Big Health
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.