510(k) K211498
- Device
- Nonin OTC Pulse Oximeter Model 3250
- Applicant
- Nonin Medical, Inc.
- 510(k) number
- K211498
- Product code
- OLK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-11-13
- Date received
- 2021-05-14
- 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
- Lisa Pray
- Address
- 13700 1st Ave. N Plymouth MN US 55441 55441
FDA Registration Numbers#
- 3004415095
Source Documents#
Other 510(k) Records For Product Code OLK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K214115 | MightySat -OTC | Masimo Corporation | 2024-01-31 |