510(k) K133298
K133298 is an FDA 510(k) premarket notification submitted by Meta Biomed, Inc. for the device "ENDO SMART". The FDA issued a decision of Substantially Equivalent on Sep 19, 2014. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. Meta Biomed, Inc. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 19, 2014
- Date Received
- Oct 25, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Handpiece, Direct Drive, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type
- 510(k)