510(k) K860025

MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR by Medicor USA , Ltd. — Product Code KPR

K860025 is an FDA 510(k) premarket notification submitted by Medicor USA , Ltd. for the device "MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR". The FDA issued a decision of Substantially Equivalent on May 7, 1986. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Medicor USA , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1986
Date Received
January 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type