BLADE GAUGE— 510(k) K812011

Substantially Equivalent

Koi, Inc.

FDA 510(k) clearance K812011 for BLADE GAUGE, Substantially Equivalent on 1981-07-28. Applicant: Koi, Inc.. Device class: 1.

Clearance details

Applicant: Koi, Inc.
Product code: Code HOE
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1981-07-17
Decision date: 1981-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code HOE

K881094 — KOI(TM) BLADE GAUGE, MODEL KOI-1321988-04-01
K813315 — CALIPER-OPTHALMIC1982-03-01
K820050 — KREMER BLADE GAUGE1982-02-24
K801937 — BLEPHAROMETER1980-09-16
K792383 — KELMAN DIPSTICK1979-12-11

More clearances from Koi, Inc.

K843247 — KOI PACHYMETER1986-04-30
K830366 — DIAMOND KNIFE1983-03-09
K812764 — KOI BLUE FIELD ENTOPTOSCOPE1981-12-02
K812450 — KOI DIAMOND KNIFE1981-09-21
K812097 — KOI LACREMAL HOOK & DILATOR1981-08-18

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