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510(k) K043554

ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 by B-K Medical A/S — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2005
Date Received
December 27, 2004
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 B-K Medical A/S

  • K043524 — ULTRASOUND SCANNER PRO FOCUS, MODEL 2202 (January 13, 2005)
  • K024236 — ULTRASOUND SCANNER, TYPE 2400 (January 17, 2003)
  • K023457 — ULTRASOUND SCANNER, TYPE 1101 (November 1, 2002)
  • K011417 — ULTRASOUND SCANNER, TYPE 2102 (June 8, 2001)
  • K003986 — ULTRASOUND SCANNER TYPE 2102 (April 3, 2001)
  • K003041 — ULTRASOUND SCANNER TYPE 2101 (February 7, 2001)

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