510(k) K833558
K833558 is an FDA 510(k) premarket notification submitted by Moyco Industries, Inc. for the device "X-RAY SHIELD". The FDA issued a decision of Substantially Equivalent on January 13, 1984. The device falls under product code EHB (Collimator, X-Ray), a Class I device regulated under 21 CFR 872.1840. Moyco Industries, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 1984
- Date Received
- October 13, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collimator, X-Ray
- Device Class
- Class I
- Regulation Number
- 872.1840
- Review Panel
- RA
- Submission Type