510(k) K213676

Masimo Rad-G with Temperature by Masimo Corporation — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2023
Date Received
November 22, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type