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510(k) K771864

WALL TRANSFORMERS 74710 & 74910 by Welch Allyn, Inc. — Product Code GCW

K771864 is an FDA 510(k) premarket notification submitted by Welch Allyn, Inc. for the device "WALL TRANSFORMERS 74710 & 74910". The FDA issued a decision of Substantially Equivalent on November 22, 1977. The device falls under product code GCW (Transformer, Endoscope), a Class II device regulated under 21 CFR 876.1500. Welch Allyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1977
Date Received
October 3, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transformer, Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Welch Allyn, Inc.

  • K243598 — Welch Allyn Connex® 360 (Multiple) (July 13, 2025)
  • K241411 — Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) (December 20, 2024)
  • K223381 — iExaminer System with Panoptic Plus (March 15, 2023)
  • K212473 — Welch Allyn Connex Central Station (October 28, 2022)
  • K191013 — Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option (September 10, 2019)
  • K181016 — Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System (July 16, 2018)
  • K171621 — Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall Syste (June 30, 2017)
  • K142356 — Connex Spot Monitor,901058 Vital Signs Monitor Core (December 19, 2014)
  • K141582 — CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION (July 11, 2014)
  • K132807 — MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) (January 31, 2014)

FDA data resources