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510(k) K081919

UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM by Fukuda Denshi Co., Ltd. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2008
Date Received
July 7, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Fukuda Denshi Co., Ltd.

  • K110920 — UF-760AG (April 8, 2011)

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