510(k) DEN210039
- Device
- SNOO Smart Sleeper
- Applicant
- Happiest Baby, Inc.
- 510(k) number
- DEN210039
- Product code
- QTG
- Decision
- Unknown (DENG)
- Decision date
- 2023-03-30
- Date received
- 2021-09-20
- Regulation
- 880.5690
- Classification name
- Infant Supine Sleep System
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Harvey Karp
- Address
- 3115 S. La Cienega Blvd. Los Angeles CA US 90016 90016
FDA Registration Numbers#
- 3013375997
- 3030187577
- 1531264
Source Documents#
510(k) summary PDF not indicated by FDA