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510(k) K080223

ZURA TEE SYSTEM by Imacor, LLC — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2008
Date Received
January 29, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

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  • K100989 — ZURA TEE SYSTEM WITH CLARITEE PROBE (June 25, 2010)

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