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510(k) K905198

DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535 by Bruel & Kjaer — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1991
Date Received
November 20, 1990
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 Bruel & Kjaer

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  • K914295 — ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED (April 10, 1992)
  • K911348 — RIGID ENDOSCOPE (June 21, 1991)

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