510(k) K832805
K832805 is an FDA 510(k) premarket notification submitted by Murray Electronics for the device "BIONICARE STIMULATOR BIO-1". The FDA issued a decision of Substantially Equivalent on December 23, 1983. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Murray Electronics has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 1983
- Date Received
- August 18, 1983
- 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