WELCH ALLYN BI-OTOSCOPE— 510(k) K955043

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K955043 for WELCH ALLYN BI-OTOSCOPE, Substantially Equivalent on 1995-11-14. Applicant: Welch Allyn, Inc.. Device class: 1.

Clearance details

Applicant: Welch Allyn, Inc.
Product code: Code ERA
Device class: Class 1
Regulation: 21 CFR 874.4770
Advisory panel: Ear, Nose, Throat
Date received: 1995-11-03
Decision date: 1995-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skaneateles Falls, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ERA

K123821 — AIO HD OTOSCOPE2013-05-17
K121326 — LANTOS 3D EAR SCANNER2013-01-25
K110326 — OSRAM ITOS2011-10-27
K945264 — OPTUS OTOSCOPES1996-02-02
K952578 — WELCH ALLY OTOSCOPE1995-07-10

More clearances from Welch Allyn, Inc.

K243598 — Welch Allyn Connex® 360 (Multiple)2025-07-13
K241411 — Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)2024-12-20
K223381 — iExaminer System with Panoptic Plus2023-03-15
K212473 — Welch Allyn Connex Central Station2022-10-28
K191013 — Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option2019-09-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.