510(k) K172625

Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor by Nonin Medical, Inc. — Product Code DQA

K172625 is an FDA 510(k) premarket notification submitted by Nonin Medical, Inc. for the device "Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor". The FDA issued a decision of Substantially Equivalent on May 11, 2018. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Nonin Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2018
Date Received
September 1, 2017
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