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510(k) K852502

AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849 by Bruel & Kjaer Industri A/S — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1986
Date Received
June 12, 1985
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 Bruel & Kjaer Industri A/S

  • K914945 — DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED (June 26, 1992)
  • K875357 — BIOPSY FIXATION UNIT-TYPE UA 0997 (July 1, 1988)
  • K842090 — RHINO-LARYNX STROBOSCOPE TYPE 4914 (July 18, 1984)

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