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510(k) K000368

EYECAP IMAGING SYSTEM by Clement Clarke Intl., Ltd. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2000
Date Received
February 4, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type

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  • K982334 — AIRZONE PEAK FLOWMETER (January 14, 1999)
  • K980960 — IN-CHECK INSPIRATORY FLOWMETER (June 10, 1998)
  • K962074 — VM PLUS PEAK FLOWMETER (January 2, 1997)

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