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510(k) K900838

TRANSVAGINAL TRANSDUCER ASSEMBLY by Pie Medical Equipment B.V. — Product Code HGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1990
Date Received
February 22, 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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  • K881263 — MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER (January 5, 1990)
  • K895647 — 5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER (December 18, 1989)