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510(k) K131433

ISYS 1 (U.S),ACCESSORY, NON-STERILE by Isys Medizintechnik GmbH — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2014
Date Received
May 17, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

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