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510(k) K003041

ULTRASOUND SCANNER TYPE 2101 by B-K Medical A/S — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2001
Date Received
September 29, 2000
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

Other clearances by B-K Medical A/S

  • K043554 — ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 (January 14, 2005)
  • 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)

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