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510(k) K950797

HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134 by Neitz Instruments Company, Ltd. — Product Code HLJ

K950797 is an FDA 510(k) premarket notification submitted by Neitz Instruments Company, Ltd. for the device "HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134". The FDA issued a decision of Substantially Equivalent on March 28, 1995. The device falls under product code HLJ (Ophthalmoscope, Battery-Powered), a Class II device regulated under 21 CFR 886.1570. Neitz Instruments Company, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1995
Date Received
February 21, 1995
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 Neitz Instruments Company, Ltd.

  • K972440 — CATARACTSCREENER CT - S (September 30, 1997)
  • K951341 — NEITZ SLIT LAMP SL-H2 (June 15, 1995)
  • K951337 — FIBER HEAD LIGHT FH-300 (June 8, 1995)
  • K950788 — OTOSCOPE A-34 (May 3, 1995)
  • K951340 — NEITZ SLIT LAMP SL-H1 (April 10, 1995)
  • K951338 — INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV (April 7, 1995)
  • K950794 — STREAK RETINOSCOPE RX-RC (March 28, 1995)
  • K950791 — STREAK RETINOSCOPE RX-3 (March 28, 1995)
  • K950792 — STREAK RETINOSCOPE RX-3A (March 28, 1995)
  • K950789 — STREAK RETINOSCOPE RX-1 (March 28, 1995)

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