CALIPER-OPTHALMIC— 510(k) K813315

Substantially Equivalent

Design Research Assoc., Inc.

FDA 510(k) clearance K813315 for CALIPER-OPTHALMIC, Substantially Equivalent on 1982-03-01. Applicant: Design Research Assoc., Inc.. Device class: 1.

Clearance details

Applicant: Design Research Assoc., Inc.
Product code: Code HOE
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1981-11-24
Decision date: 1982-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HOE

K881094 — KOI(TM) BLADE GAUGE, MODEL KOI-1321988-04-01
K820050 — KREMER BLADE GAUGE1982-02-24
K812011 — BLADE GAUGE1981-07-28
K801937 — BLEPHAROMETER1980-09-16
K792383 — KELMAN DIPSTICK1979-12-11

More clearances from Design Research Assoc., Inc.

K813313 — BIOMICROSCOPY CONTACT LENS1982-03-01
K813314 — NLD IMPLANT SET1982-02-24

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