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510(k) K970029

KEELER SPECTRA INDIRECT OPHTHALMOSCOPE by Keeler Instruments, Inc. — Product Code HLJ

K970029 is an FDA 510(k) premarket notification submitted by Keeler Instruments, Inc. for the device "KEELER SPECTRA INDIRECT OPHTHALMOSCOPE". The FDA issued a decision of Substantially Equivalent on April 2, 1997. The device falls under product code HLJ (Ophthalmoscope, Battery-Powered), a Class II device regulated under 21 CFR 886.1570. Keeler Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1997
Date Received
January 3, 1997
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 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 HLJ

  • K142486 — HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 (May 18, 2015)
  • K142837 — HEINE SIGMA 250 & HEINE SIGMA 250 M2 (January 29, 2015)
  • K131959 — HEINE MINI 3000(R) OPHTHALMOSCOPE (March 7, 2014)
  • K131961 — HEINE BETA 200(R) OPHTHALMOSCOPE (December 4, 2013)
  • K131719 — OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS (October 30, 2013)
  • K123587 — HEINE MINI 3000 LED OPHTHALMOSCOPE (March 22, 2013)
  • K093495 — OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS (November 19, 2010)
  • 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)
  • K061278 — OPTYSE OPHTHALMOSCOPE (May 16, 2006)

FDA data resources