510(k) K870563
K870563 is an FDA 510(k) premarket notification submitted by X-Tech, Ltd. for the device "X-RAY APRON". The FDA issued a decision of Substantially Equivalent on February 19, 1987. The device falls under product code EAJ (Apron, Leaded), a Class I device regulated under 21 CFR 892.6500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 1987
- Date Received
- February 10, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apron, Leaded
- Device Class
- Class I
- Regulation Number
- 892.6500
- Review Panel
- RA
- Submission Type