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510(k) K903348

ULTRASONIC PULSED DOPPLER IMAGING SYSTEM by Advanced Technology Laboratories, Inc. — Product Code HGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1990
Date Received
July 26, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Obstetric
Device Class
Class II
Regulation Number
884.2960
Review Panel
OB
Submission Type

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  • K900838 — TRANSVAGINAL TRANSDUCER ASSEMBLY (May 23, 1990)
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  • K881263 — MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER (January 5, 1990)
  • K895647 — 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER (December 18, 1989)