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510(k) K875357

BIOPSY FIXATION UNIT-TYPE UA 0997 by Bruel & Kjaer Industri A/S — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1988
Date Received
December 31, 1987
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

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  • K852502 — AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849 (October 23, 1986)
  • K842090 — RHINO-LARYNX STROBOSCOPE TYPE 4914 (July 18, 1984)

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