510(k) K163317
K163317 is an FDA 510(k) premarket notification submitted by Kaltenbach & Voigt Gmgh for the device "ELECTROmatic". The FDA issued a decision of Substantially Equivalent on Feb 21, 2017. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 21, 2017
- Date Received
- Nov 23, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Controller, Foot, Handpiece And Cord
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type
- 510(k)