510(k) K834293
K834293 is an FDA 510(k) premarket notification submitted by Electronic Energy, Inc. for the device "ELECTRONIC CELL ENERGIZER". The FDA issued a decision of Substantially Equivalent on January 13, 1984. The device falls under product code LBG (Device, Fluidized Therapy, Dry Heat), a Class II device regulated under 21 CFR 890.5500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 1984
- Date Received
- December 8, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Fluidized Therapy, Dry Heat
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- PM
- Submission Type