510(k) K802804
K802804 is an FDA 510(k) premarket notification submitted by Nemectron Medical, Inc. for the device "NEMECTRODYN 8". The FDA issued a decision of Substantially Equivalent on March 16, 1981. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Nemectron Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 1981
- Date Received
- November 5, 1980
- 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