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510(k) K955043

WELCH ALLYN BI-OTOSCOPE by Welch Allyn, Inc. — Product Code ERA

K955043 is an FDA 510(k) premarket notification submitted by Welch Allyn, Inc. for the device "WELCH ALLYN BI-OTOSCOPE". The FDA issued a decision of Substantially Equivalent on November 14, 1995. The device falls under product code ERA (Otoscope), a Class I device regulated under 21 CFR 874.4770. Welch Allyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1995
Date Received
November 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Otoscope
Device Class
Class I
Regulation Number
874.4770
Review Panel
EN
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)

Other clearances for product code ERA

  • K123821 — AIO HD OTOSCOPE (May 17, 2013)
  • K121326 — LANTOS 3D EAR SCANNER (January 25, 2013)
  • K110326 — OSRAM ITOS (October 27, 2011)
  • K945264 — OPTUS OTOSCOPES (February 2, 1996)
  • K952578 — WELCH ALLY OTOSCOPE (July 10, 1995)
  • K950913 — PERFECT, ENT SET, PRAKTIKANT, DE LUXE (May 12, 1995)
  • K950788 — OTOSCOPE A-34 (May 3, 1995)
  • K951049 — SPECULUM, ENT (S3) (April 17, 1995)
  • K951050 — SPECULUM, ENT (S3) (April 17, 1995)
  • K951255 — IMEDGE VIDEO OSTOSCOPE (ANALOG) (April 13, 1995)

FDA data resources