510(k) K922165
K922165 is an FDA 510(k) premarket notification submitted by Gendex Corp. for the device "ATC725, ATC525, AND AP300". The FDA issued a decision of Substantially Equivalent on July 27, 1992. 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
- July 27, 1992
- Date Received
- May 8, 1992
- 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