COMPUTERIZED PUPIL— 510(k) K920937

Substantially Equivalent

Trek Medical Products, Inc.

FDA 510(k) clearance K920937 for COMPUTERIZED PUPIL, Substantially Equivalent on 1992-10-02. Applicant: Trek Medical Products, Inc.. Device class: 1.

Clearance details

Applicant: Trek Medical Products, Inc.
Product code: Code HLG
Device class: Class 1
Regulation: 21 CFR 886.1700
Advisory panel: Ophthalmic
Date received: 1992-02-27
Decision date: 1992-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Muckwonago, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HLG

K895609 — PUPIL PATHWAY ANALYZER (PPA)1989-11-02
K802351 — F110 PHOTO BINOCULAR OPHTHALMOSCOPE1980-12-17

More clearances from Trek Medical Products, Inc.

K920944 — FTS-200 GAS SYSTEM1992-05-29
K900808 — RAPID AUTOMATIC PNEUMOPERITONEUM-I1990-09-19
K902784 — FIBER OPTIC LIGHT SOURCE1990-09-12
K895813 — GLAUCOMA MECHANICAL TREPHINE1990-04-30
K882403 — OPHTHALMIC FLUID INJECTOR1988-09-09

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