Cleared Traditional

K771864 - WALL TRANSFORMERS 74710 & 74910 (FDA 510(k) Clearance)

Nov 1977
Decision
50d
Days
Class 2
Risk

K771864 is an FDA 510(k) clearance for the WALL TRANSFORMERS 74710 & 74910. This device is classified as a Transformer, Endoscope (Class II - Special Controls, product code GCW).

Submitted by Welch Allyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1977, 50 days after receiving the submission on October 3, 1977.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K771864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1977
Decision Date November 22, 1977
Days to Decision 50 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary

Device Classification

Product Code GCW — Transformer, Endoscope
Device Class Class II - Special Controls
CFR Regulation 21 CFR 876.1500