510(k) K811230
K811230 is an FDA 510(k) premarket notification submitted by X-Cel X-Ray Corp. for the device "X-CELL X-RAY #'S P-75W/P-75M". The FDA issued a decision of Substantially Equivalent on June 23, 1981. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. X-Cel X-Ray Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 1981
- Date Received
- May 4, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type