Prapela SVS hospital bassinet pad (model P01)
FDA 510(k) clearance DEN240031 · decided 2025-04-04
Clearance details
- K-number
- DEN240031
- Device name
- Prapela SVS hospital bassinet pad (model P01)
- Applicant
- Prapela, Inc.
- Decision
- Unknown
- Date received
- 2024-06-17
- Decision date
- 2025-04-04
- Days to decision
- 291 days
- Clearance type
- Direct
- Product code
- QVY
- Device class
- 2
- Regulation number
- 880.5151
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Biddeford, ME, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.