510(k) K121969
K121969 is an FDA 510(k) premarket notification submitted by Taidoc Technology Corporation for the device "U-RIGHT COMPRESSOR NEBULIZER". The FDA issued a decision of Substantially Equivalent on Feb 28, 2013. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Taidoc Technology Corporation has 122 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 28, 2013
- Date Received
- Jul 5, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Nebulizer (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type
- 510(k)