510(k) K881589
K881589 is an FDA 510(k) premarket notification submitted by Continental X-Ray Corp. for the device "14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400". The FDA issued a decision of Substantially Equivalent on July 18, 1988. The device falls under product code IXL (Device, Spot-Film), a Class II device regulated under 21 CFR 892.1670. Continental X-Ray Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 1988
- Date Received
- April 13, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Spot-Film
- Device Class
- Class II
- Regulation Number
- 892.1670
- Review Panel
- RA
- Submission Type