Home / 510(k) Clearances / K161960

510(k) K161960

bk2300 by Bk Medical Aps — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2016
Date Received
July 18, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

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  • K152052 — Ultrasound Scanner System bk2300 (September 16, 2015)
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