Cleared Traditional

DIGI-INJECTOR

K971067 · Medical Instrument Development Laboratories, Inc. · Ophthalmic
Sep 1997
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K971067 is an FDA 510(k) clearance for the DIGI-INJECTOR, a Pump, Infusion, Ophthalmic (Class II — Special Controls, product code MRH), submitted by Medical Instrument Development Laboratories, Inc. (San Leandro, US). The FDA issued a Cleared decision on September 19, 1997, 179 days after receiving the submission on March 24, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K971067 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1997
Decision Date September 19, 1997
Days to Decision 179 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code MRH — Pump, Infusion, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725