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510(k) K854422

SERIES 25 SLIMLINE CRYO PROBES by Keeler Instruments, Inc. — Product Code HQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1985
Date Received
November 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryotherapy, Ophthalmic
Device Class
Class II
Regulation Number
886.4170
Review Panel
OP
Submission Type

Other clearances by Keeler Instruments, Inc.

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  • K112093 — CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER (December 8, 2011)
  • K093298 — PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 (December 10, 2010)
  • K100500 — PSL CLASSIC SLIT LAMP (March 9, 2010)
  • K062412 — CRYOMATIC (November 6, 2006)
  • K060822 — VANTAGE INDIRECT OPHTHALMOSCOPE (May 23, 2006)
  • K032087 — KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 (November 26, 2003)
  • K992954 — KEELER CRYO MASTER & PROBES (December 21, 1999)
  • K990257 — KEELER PULSAIR 3000 NON CONTACT TONOMETER (March 25, 1999)
  • K973064 — KEELER TEARSCOPE-PLUS (April 7, 1998)

Other clearances for product code HQA

  • K854411 — KEELER-COMPACT CRYO SYSTEM (December 30, 1985)
  • K841294 — ACU220 CRYO UNIT (August 15, 1984)
  • K823835 — SPEMBLY 140 CRYOSYSTEM PROBES & TIPS (January 17, 1983)