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510(k) K863589

MODEL 600 VASCULAR DUPLEX IMAGER by Multigon Industries, Inc. — Product Code DXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1987
Date Received
September 15, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Echocardiograph
Device Class
Class II
Regulation Number
870.2330
Review Panel
CV
Submission Type

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  • K860435 — MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER (May 5, 1986)
  • K852680 — TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG (December 23, 1985)

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