510(k) K844180

THE MCP-70-SE SYSTEM by Ellis Pharmaceutical Consulting, Inc. — Product Code KQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1985
Date Received
October 26, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Beam Limiting, X-Ray, Therapeutic
Device Class
Class II
Regulation Number
892.5900
Review Panel
RA
Submission Type