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510(k) K951393

ABACUS OB ULTRASOUNG COMPUTER SOFTWARE by Solomon Technology Labs — Product Code HEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1995
Date Received
March 27, 1995
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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