Cleared Traditional

K852949 - WELCH ALLYN #48100 TASK LITE W/ACCESSORIES AS LIST (FDA 510(k) Clearance)

Sep 1985
Decision
55d
Days
Class 1
Risk

K852949 is an FDA 510(k) clearance for the WELCH ALLYN #48100 TASK LITE W/ACCESSORIES AS LIST. This device is classified as a Device, Medical Examination, Ac Powered (Class I - General Controls, product code KZF).

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on September 4, 1985, 55 days after receiving the submission on July 11, 1985.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6320.

Submission Details

510(k) Number K852949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1985
Decision Date September 04, 1985
Days to Decision 55 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code KZF — Device, Medical Examination, Ac Powered
Device Class Class I - General Controls
CFR Regulation 21 CFR 880.6320