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510(k) K222441

Ultrasound System 2300 by Bk Medical Aps — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2022
Date Received
August 12, 2022
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

Other clearances by Bk Medical Aps

  • K231764 — Ultrasound System 1300 (October 23, 2023)
  • K223830 — Ultrasound System 2300 (April 11, 2023)
  • 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)
  • K152052 — Ultrasound Scanner System bk2300 (September 16, 2015)
  • K143298 — Ultrasound Scanner System bk2300 (January 16, 2015)

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