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510(k) K083254

ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM by Aloka Co., Ltd. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2008
Date Received
November 4, 2008
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

Other clearances by Aloka Co., Ltd.

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  • K110207 — ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM (February 17, 2011)
  • K093488 — ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM (November 20, 2009)
  • K081843 — ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 (July 15, 2008)
  • K080176 — ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM (February 29, 2008)
  • K072285 — ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM (August 30, 2007)
  • K060059 — ALOKA SD-3500 ULTRASOUND SYSTEM (January 13, 2006)
  • K043196 — ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM (November 30, 2004)
  • K040719 — ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM (March 26, 2004)
  • K033311 — ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM (October 29, 2003)

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