510(k) K031375
K031375 is an FDA 510(k) premarket notification submitted by Besmed Health Business Corp for the device "BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580". The FDA issued a decision of Substantially Equivalent on November 20, 2003. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Besmed Health Business Corp has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 2003
- Date Received
- April 30, 2003
- 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