RETINA TESTER— 510(k) K914393

Substantially Equivalent

Retina Tester

FDA 510(k) clearance K914393 for RETINA TESTER, Substantially Equivalent on 1992-03-02. Applicant: Retina Tester. Device class: 2.

Clearance details

Applicant: Retina Tester
Product code: Code HLX
Device class: Class 2
Regulation: 21 CFR 886.1630
Advisory panel: Ophthalmic
Date received: 1991-10-01
Decision date: 1992-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HLX

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K925741 — CLARUS ENDOSCOPIC HOOK KNIFE1993-08-24
K914163 — SCOPTOPIC SENSITIVITY TEST-1[SST-1]1991-10-25
K873990 — IRAS EDS INTERFEROMETRIC STIMULATOR1988-02-05

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