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510(k) K843437

MEI MAMMOGRAPHY SYS MX-2049 by Moti Enterprises, Inc. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1984
Date Received
September 4, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type

Other clearances by Moti Enterprises, Inc.

  • K810095 — MOTI APRON (February 12, 1981)
  • K802377 — MOTI PROTECTIVE X-RAY MASK (October 31, 1980)

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