510(k) K100427
K100427 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY". The FDA issued a decision of Substantially Equivalent on May 28, 2010. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Taidoc Technology Corporation has 122 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 2010
- Date Received
- Feb 16, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device Class
- Class II
- Regulation Number
- 870.2910
- Review Panel
- CV
- Submission Type
- 510(k)