510(k) DEN240031

Device

Prapela SVS hospital bassinet pad (model P01)

Applicant

Prapela, Inc.

510(k) number

DEN240031

Product code

QVY

Decision

Unknown (DENG)

Decision date

2025-04-04

Date received

2024-06-17

Regulation

880.5151

Classification name

Therapeutic Vibrational Mattress Pad, Adjunct Use In Neonatal Abstinence Syndrome Or Neonatal Opioid Withdrawal Syndrome

Medical specialty

General Hospital

Review panel

General Hospital

Device class

2

Clearance type

Direct

Third party reviewed

N