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510(k) K031391

HF MODULE WITH TRANSDUCERS by Ophthalmic Technologies, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2003
Date Received
May 2, 2003
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

Other clearances by Ophthalmic Technologies, Inc.

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  • K030770 — OTI SCAN WITH TRANSDUCERS (March 27, 2003)
  • K024114 — A-SCAN 100 (January 10, 2003)
  • K990064 — DI-RHEX OPHTHALMIC DIATHERMY SYSTEM (April 4, 1999)
  • K974522 — 3D I-SCAN (February 25, 1998)
  • K971679 — I-SCOPE OPHTHALMIC ENDOSCOPE (June 25, 1997)
  • K960622 — I-SCAN (May 13, 1996)
  • K954263 — XE-LITE (October 18, 1995)

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