510(k) K101012

V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201 by Taidoc Technology Corporation — Product Code DQA

K101012 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201". The FDA issued a decision of Substantially Equivalent on Dec 15, 2010. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Taidoc Technology Corporation has 122 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 15, 2010
Date Received
Apr 12, 2010
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
510(k)

Source: FDA 510(k) database entry for K101012. Report a data issue: hello@regdatalab.com.