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510(k) K850478

PLUS 1 by Dymax Corp — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1985
Date Received
February 11, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

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  • K903158 — SITERITE NEEDLE GUIDE (September 27, 1990)
  • K894415 — DYMAX ENDOVAGINAL BIOPSY GUIDE (October 25, 1989)
  • K862127 — DYMAX PERSONAL SCANNER (December 11, 1986)

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