IRAS GLARE TESTER— 510(k) K873987

Substantially Equivalent

Randwal Instrument Co., Inc.

FDA 510(k) clearance K873987 for IRAS GLARE TESTER, Substantially Equivalent on 1987-11-24. Applicant: Randwal Instrument Co., Inc.. Device class: 2.

Clearance details

Applicant: Randwal Instrument Co., Inc.
Product code: Code HLJ
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1987-09-29
Decision date: 1987-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southbridge, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HLJ

K142486 — HEINE BETA 200, HEINE BETA 200 S, HEINE K 1802015-05-18
K142837 — HEINE SIGMA 250 & HEINE SIGMA 250 M22015-01-29
K131959 — HEINE MINI 3000(R) OPHTHALMOSCOPE2014-03-07
K131961 — HEINE BETA 200(R) OPHTHALMOSCOPE2013-12-04
K131719 — OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS2013-10-30

More clearances from Randwal Instrument Co., Inc.

K873990 — IRAS EDS INTERFEROMETRIC STIMULATOR1988-02-05
K864012 — IRAS PERIMETER1986-12-12
K853556 — LASER IRAS1985-11-01
K842567 — PORTABLE ACUIOMETER1984-08-15
K827577 — VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER1983-01-24

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