Cleared Traditional

BREATH-EASY, MODIFICATION

K914416 · Icor AB · Ophthalmic
Jun 1992
Decision
272d
Days
Class 1
Risk

About This 510(k) Submission

K914416 is an FDA 510(k) clearance for the BREATH-EASY, MODIFICATION, a Chair, Ophthalmic, Ac-powered (Class I — General Controls, product code HME), submitted by Icor AB (Bromma, SE). The FDA issued a Cleared decision on June 23, 1992, 272 days after receiving the submission on September 25, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1140.

Submission Details

510(k) Number K914416 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1991
Decision Date June 23, 1992
Days to Decision 272 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HME — Chair, Ophthalmic, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1140

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