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510(k) K131589

KEELER SLIT LAMP H-SERIES by Keeler, Ltd. — Product Code HJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2013
Date Received
May 31, 2013
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

Other clearances by Keeler, Ltd.

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  • K131787 — CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES (December 23, 2013)
  • K093445 — KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) (January 19, 2010)

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  • K170470 — Digital Eye Anterior Camera (October 6, 2017)
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