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510(k) K122341

PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 by Hitachi Aloka Medical, Ltd. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2012
Date Received
August 2, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

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  • K130308 — NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM (April 5, 2013)
  • K123828 — PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM (January 18, 2013)

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