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510(k) K841292

SPECTACLE INDIRECT OPHTHALMOSCOPE by Keller Instruments, Inc. — Product Code HLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1984
Date Received
March 29, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Battery-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Other clearances by Keller Instruments, Inc.

  • K854541 — TIP OFF FORCEPS (December 17, 1985)
  • K841294 — ACU220 CRYO UNIT (August 15, 1984)
  • K841293 — PANORAMIC LOUPES - VARIOUS (May 9, 1984)
  • K823835 — SPEMBLY 140 CRYOSYSTEM PROBES & TIPS (January 17, 1983)

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  • K070270 — PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 (November 5, 2007)
  • K052599 — 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25 (November 7, 2006)
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