KOI BLUE FIELD ENTOPTOSCOPE— 510(k) K812764

Substantially Equivalent

Koi, Inc.

FDA 510(k) clearance K812764 for KOI BLUE FIELD ENTOPTOSCOPE, Substantially Equivalent on 1981-12-02. Applicant: Koi, Inc.. Device class: 2.

Clearance details

Applicant: Koi, Inc.
Product code: Code HKL
Device class: Class 2
Regulation: 21 CFR 886.1780
Advisory panel: Ophthalmic
Date received: 1981-10-02
Decision date: 1981-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HKL

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K893171 — VISTA STREAK RETINOSCOPE (AC-POWERED)1989-09-21
K800238 — MOIRE FRINGE VISOMETER AFTER LOTMAR1980-03-10

More clearances from Koi, Inc.

K843247 — KOI PACHYMETER1986-04-30
K830366 — DIAMOND KNIFE1983-03-09
K812450 — KOI DIAMOND KNIFE1981-09-21
K812097 — KOI LACREMAL HOOK & DILATOR1981-08-18
K812010 — KOI LACRIMAL INTUBATION SYSTEM1981-07-28

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