STREAK RETINOSCOPE RX-3— 510(k) K950791

Name: FDA 510(k) clearance K950791
Creator: U.S. Food and Drug Administration
Published: 1995-03-28

Substantially Equivalent

Neitz Instruments Company, Ltd.

FDA 510(k) clearance K950791 for STREAK RETINOSCOPE RX-3, Substantially Equivalent on 1995-03-28. Applicant: Neitz Instruments Company, Ltd.. Device class: 1.

Clearance details

Applicant: Neitz Instruments Company, Ltd.
Product code: Code HKM
Device class: Class 1
Regulation: 21 CFR 886.1780
Advisory panel: Ophthalmic
Date received: 1995-02-21
Decision date: 1995-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code HKM

view all

K964338 — RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT1997-01-09
K950792 — STREAK RETINOSCOPE RX-3A1995-03-28
K950793 — SPOT RETINOSCOPE RX-3SP1995-03-28
K950794 — STREAK RETINOSCOPE RX-RC1995-03-28
K950795 — STREAK RETINOSCOPE RX-RP1995-03-28

More clearances from Neitz Instruments Company, Ltd.

view all

K972440 — CATARACTSCREENER CT - S1997-09-30
K951341 — NEITZ SLIT LAMP SL-H21995-06-15
K951337 — FIBER HEAD LIGHT FH-3001995-06-08
K950788 — OTOSCOPE A-341995-05-03
K951340 — NEITZ SLIT LAMP SL-H11995-04-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.