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510(k) K090433

I_OPEN 0.4T by Beijing Wandong Medical Equipment Co., Ltd. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2009
Date Received
February 19, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type

Other clearances by Beijing Wandong Medical Equipment Co., Ltd.

  • K090873 — I OPEN 0.5T (April 10, 2009)

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