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510(k) K904951

S5192R TRANSDUCER by Acuson Corp. — Product Code MAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1991
Date Received
November 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Fetal Doppler Ultrasound
Device Class
Class II
Regulation Number
884.2660
Review Panel
RA
Submission Type

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  • K905456 — L328 TRANSDUCER (May 28, 1991)
  • K895909 — SONICAID MODEL VASOFLO 4 (July 9, 1990)
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