510(k) K940301
K940301 is an FDA 510(k) premarket notification submitted by Biodex Medical Systems, Inc. for the device "COMPEX 2". The FDA issued a decision of SN on December 28, 1994. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Biodex Medical Systems, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- December 28, 1994
- Date Received
- January 24, 1994
- 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