CONTRAST SENSITIVITY EQUIPMENT— 510(k) K830770

Name: FDA 510(k) clearance K830770
Creator: U.S. Food and Drug Administration
Published: 1983-04-28

Substantially Equivalent

Cadwell Laboratories, Inc.

FDA 510(k) clearance K830770 for CONTRAST SENSITIVITY EQUIPMENT, Substantially Equivalent on 1983-04-28. Applicant: Cadwell Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cadwell Laboratories, Inc.
Product code: Code HLX
Device class: Class 2
Regulation: 21 CFR 886.1630
Advisory panel: Ophthalmic
Date received: 1983-03-11
Decision date: 1983-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HLX

view all

K003442 — MODIFICATION TO EDI VERIS SYSTEM2001-05-04
K983983 — EDI VERIS SYSTEM1999-02-03
K925741 — CLARUS ENDOSCOPIC HOOK KNIFE1993-08-24
K914393 — RETINA TESTER1992-03-02
K914163 — SCOPTOPIC SENSITIVITY TEST-1[SST-1]1991-10-25

More clearances from Cadwell Laboratories, Inc.

view all

K061706 — CADWELL EASYNET OXIMETER MODULE2007-03-05
K061705 — CADWELL EASYNET NASAL PRESSURE MODULE2006-11-21
K042350 — TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR2004-11-03
K040932 — EASYNET BODY POSITION MODULE2004-07-01
K040986 — CADWELL LIMB MOVEMENT MODULE2004-07-01

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