510(k) K234021
- Device
- Masimo Stork
- Applicant
- Masimo Corporation
- 510(k) number
- K234021
- Product code
- QYU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-05-03
- Date received
- 2023-12-20
- Regulation
- 870.2705
- Classification name
- Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kertana Shankar
- Address
- 52 Discovery Irvine CA US 92618 92618
FDA Registration Numbers#
- 3003899230
- 3012977166
- 3004415095
- 3019388613
- 3011353843
Source Documents#
Other 510(k) Records For Product Code QYU#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN220091 | Dream Sock | Owlet Babycare, Inc. | 2023-11-08 |