510(k) K214115
- Device
- MightySat -OTC
- Applicant
- Masimo Corporation
- 510(k) number
- K214115
- Product code
- OLK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-01-31
- Date received
- 2021-12-30
- Regulation
- 870.2700
- Classification name
- Pulse Oximeter 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#
- 3004415095
Source Documents#
Other 510(k) Records For Product Code OLK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K211498 | Nonin OTC Pulse Oximeter Model 3250 | Nonin Medical, Inc. | 2024-11-13 |