Cleared Traditional

K781658 - PROJECTOR, ACCU-CHART ACUITY (FDA 510(k) Clearance)

Oct 1978
Decision
19d
Days
Class 1
Risk

K781658 is an FDA 510(k) clearance for the PROJECTOR, ACCU-CHART ACUITY. This device is classified as a Projector, Ophthalmic (Class I - General Controls, product code HOS).

Submitted by Bausch & Lomb, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1978, 19 days after receiving the submission on September 28, 1978.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1680.

Submission Details

510(k) Number K781658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1978
Decision Date October 17, 1978
Days to Decision 19 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -

Device Classification

Product Code HOS - Projector, Ophthalmic
Device Class Class I - General Controls
CFR Regulation 21 CFR 886.1680