510(k) K151024

Finger Type Pulse Oximeter by Taidoc Technology Corporation — Product Code DQA

K151024 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "Finger Type Pulse Oximeter". The FDA issued a decision of Substantially Equivalent on March 2, 2016. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Taidoc Technology Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2016
Date Received
April 16, 2015
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