510(k) K883081
K883081 is an FDA 510(k) premarket notification submitted by Radkor, Inc. for the device "RADKOR, XG-515". The FDA issued a decision of Substantially Equivalent on Sep 2, 1988. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Radkor, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 2, 1988
- Date Received
- Jul 21, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, High-Voltage, X-Ray, Diagnostic
- Device Class
- Class I
- Regulation Number
- 892.1700
- Review Panel
- RA
- Submission Type