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510(k) K152052

Ultrasound Scanner System bk2300 by Bk Medical Aps — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2015
Date Received
July 23, 2015
Clearance Type
Special
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

Other clearances by Bk Medical Aps

  • K231764 — Ultrasound System 1300 (October 23, 2023)
  • K223830 — Ultrasound System 2300 (April 11, 2023)
  • K222441 — Ultrasound System 2300 (December 7, 2022)
  • K180737 — Ultrasound Scanner System bk2300 (August 1, 2018)
  • K173569 — Ultrasound System 1300 (February 23, 2018)
  • K161960 — bk2300 (October 17, 2016)
  • K151910 — Ultrasound Scanner System BK2300 (October 5, 2015)
  • K143298 — Ultrasound Scanner System bk2300 (January 16, 2015)

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