510(k) K854499
K854499 is an FDA 510(k) premarket notification submitted by Gendex Corp. for the device "GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR". The FDA issued a decision of Substantially Equivalent on April 22, 1986. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Gendex Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 1986
- Date Received
- November 12, 1985
- 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