510(k) K884930
K884930 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "COMPAX MODEL 40, 400, 400T". The FDA issued a decision of Substantially Equivalent on December 22, 1988. The device falls under product code IZZ (Table, Radiographic, Non-Tilting, Powered), a Class II device regulated under 21 CFR 892.1980. General Electric Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 1988
- Date Received
- November 25, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Radiographic, Non-Tilting, Powered
- Device Class
- Class II
- Regulation Number
- 892.1980
- Review Panel
- RA
- Submission Type