510(k) K881589

14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400 by Continental X-Ray Corp. — Product Code IXL

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