510(k) K071431
K071431 is an FDA 510(k) premarket notification submitted by Domino S.R.L. for the device "GLOBUS GENESY 1100 STIMULATOR". The FDA issued a decision of Substantially Equivalent on Sep 21, 2007. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Domino S.R.L. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 21, 2007
- Date Received
- May 23, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Stimulator, Muscle, Powered
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type
- 510(k)