510(k) K911562

EDITOR MP 800/HF-850 X-RAY CONTROL AND GENERATOR by Continental X-Ray Corp. — Product Code IZO

K911562 is an FDA 510(k) premarket notification submitted by Continental X-Ray Corp. for the device "EDITOR MP 800/HF-850 X-RAY CONTROL AND GENERATOR". The FDA issued a decision of Substantially Equivalent on October 24, 1991. The device falls under product code IZO (Generator, High-Voltage, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1700. Continental X-Ray Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1991
Date Received
April 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, High-Voltage, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1700
Review Panel
RA
Submission Type