Welch Allyn Bi-Otoscope
FDA 510(k) K955043 · Welch Allyn, Inc.
510(k) numberK955043
Submission
- Device name
- Welch Allyn Bi-Otoscope
- Applicant
- Welch Allyn, Inc.
Skaneateles Falls, NY, US - Received
- November 3, 1995
- Decision date
- November 14, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ERA – Otoscope
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4770
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code ERA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123821 | Aio HD OtoscopeERA · Traditional | Blue Focus | 05/17/2013SE |
| K121326 | Lantos 3D Ear ScannerERA · Traditional | Lantos Technologies | 01/25/2013SE |
| K110326 | Osram ItosERA · Traditional | Osram Sylvania, Inc. | 10/27/2011SE |
| K945264 | Optus OtoscopesERA · Traditional | Optus, Inc. | 02/02/1996SE |
| K952578 | Welch Ally OtoscopeERA · Traditional | Welch Allyn, Inc. | 07/10/1995SE |
| K950913 | Perfect, ENT Set, Praktikant, de LuxeERA · Traditional | Rudolf Riester GmbH & Co. KG | 05/12/1995SE |
| K950788 | Otoscope A-34ERA · Traditional | Neitz Instruments Company, Ltd. | 05/03/1995SE |
| K951050 | Speculum, ENT (S3)ERA · Traditional | Pedia Pals, Inc. | 04/17/1995SE |
| K951049 | Speculum, ENT (S3)ERA · Traditional | Pedia Pals, Inc. | 04/17/1995SE |
| K951255 | Imedge Video Ostoscope (Analog)ERA · Traditional | Introspect, Inc. | 04/13/1995SE |
More from Introspect, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243598 | Welch Allyn Connex® 360 (Multiple) · Traditional | 07/13/2025SE |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)MWI · Traditional | 12/20/2024SE |
| K223381 | iExaminer System with Panoptic PlusHKI · Traditional | 03/15/2023SE |
| K212473 | Welch Allyn Connex Central StationMWI · Traditional | 10/28/2022SE |
| K191013 | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionBZG · Traditional | 09/10/2019SE |
| K181016 | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image SystemNFJ · Traditional | 07/16/2018SE |
| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…MHX · Special | 06/30/2017SE |
| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor CoreMWI · Traditional | 12/19/2014SE |
| K141582 | CP150 Electrocardiograph with Spirometry OptionDPS · Special | 07/11/2014SE |
| K132807 | Monitoring Station, Connex(R) Central Station (CS)MWI · Special | 01/31/2014SE |
Questions and answers
When was Welch Allyn Bi-Otoscope cleared by the FDA?
Welch Allyn Bi-Otoscope (K955043) received a 510(k) decision of Substantially Equivalent on November 14, 1995, 11 days after the submission was received.
What is the product code of K955043?
The FDA product code is ERA – Otoscope, a Class I (low risk) device regulated under 21 CFR 874.4770.