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510(k) K992470

ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM by Advanced Technology Laboratories, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1999
Date Received
July 26, 1999
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

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  • K991671 — HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM (June 18, 1999)
  • K961459 — LEVEL 10 HDI (March 26, 1997)
  • K935009 — PEGASUS (October 11, 1994)
  • K940423 — NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE (July 29, 1994)
  • K905248 — NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS (February 28, 1991)
  • K903603 — ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9) (February 26, 1991)
  • K901329 — CEPHALIC DOPPLER W/ULTRAMARK 9 ULTRASOUND SYSTEM (November 23, 1990)

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