510(k) K110893
K110893 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "VTRUST FINGER TYPE PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on Nov 22, 2011. 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
- Nov 22, 2011
- Date Received
- Mar 30, 2011
- 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)