DEN240031
- 510(k) number
- DEN240031
- Device name
- Prapela SVS hospital bassinet pad (model P01)
- Applicant
- Prapela, Inc. ME · US
- Product code
- QVY — Therapeutic Vibrational Mattress Pad, Adjunct Use In
- Decision date
- 2025-04-04
- Date received
- 2024-06-17
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- General Hospital
Official FDA record: DEN240031
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.