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510(k) K881329

FETAL DOPPLER FOR ULTRAMARK 4 AND 8 by Advanced Technology Laboratories, Inc. — Product Code HEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1989
Date Received
March 30, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Imager, Ultrasonic Obstetric-Gynecologic
Device Class
Class II
Regulation Number
884.2225
Review Panel
OB
Submission Type

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