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510(k) K926251

B-SCAN OPTHALMIC ULTRASOUND IMAGING SYSTEM by Biovision, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1993
Date Received
December 14, 1992
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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  • K901636 — DIAMOND ND:YAG OPHTHALMIC LASER (June 22, 1990)

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