BedDot (G1)
FDA 510(k) clearance K253274 · decided 2026-06-25
Clearance details
- K-number
- K253274
- Device name
- BedDot (G1)
- Applicant
- Intelligent Dots, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-09-29
- Decision date
- 2026-06-25
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- BZQ
- Device class
- 2
- Regulation number
- 868.2375
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Peachtree Corner, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.