FDA 510(k) Application Details - K211498

Device Classification Name	More FDA Info for this Device
510(K) Number	K211498
Device Name	Nonin OTC Pulse Oximeter Model 3250
Applicant	Nonin Medical Inc. 13700 1st Avenue North Plymouth, MN 55441 US Other 510(k) Applications for this Company
Contact	Lisa Pray Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OLK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/14/2021
Decision Date	11/13/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review