Nonin OTC Pulse Oximeter Model 3250— 510(k) K211498

Substantially Equivalent

Nonin 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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