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510(k) K864467

HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN by Keeler Instruments, Inc. — Product Code HOO

K864467 is an FDA 510(k) premarket notification submitted by Keeler Instruments, Inc. for the device "HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN". The FDA issued a decision of Substantially Equivalent on December 15, 1986. The device falls under product code HOO (Perimeter, Ac-Powered), a Class I device regulated under 21 CFR 886.1605. Keeler Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1986
Date Received
November 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perimeter, Ac-Powered
Device Class
Class I
Regulation Number
886.1605
Review Panel
OP
Submission Type

Other clearances by Keeler Instruments, Inc.

  • K181143 — Keeler TonoCare Tonometer (February 8, 2019)
  • 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 HOO

  • K941723 — WELCH ALLYN GLAUCOMA DETECTOR (June 6, 1994)
  • K930448 — MARCO PROJECTION PERIMETER (June 21, 1993)
  • K873912 — RICHMOND VISUAL FIELD SCREENER (November 2, 1987)
  • K860115 — DIGILAB CAMBRIDGE PERIMETER (February 27, 1986)
  • K832800 — AUTOMATIC TANGENT SCREEN 50 (September 29, 1983)

FDA data resources