Nonin OTC Pulse Oximeter Model 3250— 510(k) K211498
Substantially EquivalentNonin Medical, Inc.
FDA 510(k) clearance K211498 for Nonin OTC Pulse Oximeter Model 3250, Substantially Equivalent on 2024-11-13. Applicant: Nonin Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Nonin Medical, Inc.
- Product code
- Code OLK
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
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