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510(k) K020876

ECHOSCAN, MODEL US-1800 by Nidek, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2002
Date Received
March 18, 2002
Clearance Type
Special
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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  • K990119 — EPI-STAR SURGICAL LASER SYSTER (July 27, 2000)
  • K990900 — MICROKERATOME, MODEL MK-2000 (September 24, 1999)

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