Cleared Traditional

K771900 - 71110 DESK CHARGER (FDA 510(k) Clearance)

Nov 1977
Decision
34d
Days
Class 1
Risk

K771900 is an FDA 510(k) clearance for the 71110 DESK CHARGER. This device is classified as a Exophthalmometer (Class I - General Controls, product code HLS).

Submitted by Welch Allyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 9, 1977, 34 days after receiving the submission on October 6, 1977.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1270.

Submission Details

510(k) Number K771900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1977
Decision Date November 09, 1977
Days to Decision 34 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code HLS — Exophthalmometer
Device Class Class I - General Controls
CFR Regulation 21 CFR 886.1270