Product code ERA
- Device name
- Otoscope
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.4770
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K123821 | AIO HD OTOSCOPE | Blue Focus | 2013-05-17 |
| K121326 | LANTOS 3D EAR SCANNER | Lantos Technologies | 2013-01-25 |
| K110326 | OSRAM ITOS | Osram Sylvania, Inc. | 2011-10-27 |
| K945264 | OPTUS OTOSCOPES | Optus, Inc. | 1996-02-02 |
| K955043 | WELCH ALLYN BI-OTOSCOPE | Welch Allyn, Inc. | 1995-11-14 |
| K952578 | WELCH ALLY OTOSCOPE | Welch Allyn, Inc. | 1995-07-10 |
| K950913 | PERFECT, ENT SET, PRAKTIKANT, DE LUXE | Rudolf Riester GmbH & Co. KG | 1995-05-12 |
| K950788 | OTOSCOPE A-34 | Neitz Instruments Company, Ltd. | 1995-05-03 |
| K951050 | SPECULUM, ENT (S3) | Pedia Pals, Inc. | 1995-04-17 |
| K951049 | SPECULUM, ENT (S3) | Pedia Pals, Inc. | 1995-04-17 |
| K951255 | IMEDGE VIDEO OSTOSCOPE (ANALOG) | Introspect, Inc. | 1995-04-13 |
| K950983 | IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE | Introspect, Inc. | 1995-04-12 |
| K950787 | WELCH ALLYN OTOSCOPE | Welch Allyn, Inc. | 1995-04-06 |
| K946043 | H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG | Rudolf Riester GmbH & Co. KG | 1995-03-08 |
| K943721 | OTOVIEW TELESCOPIC OTOSCOPES | Smith & Nephew, Inc. | 1994-11-18 |
| K944897 | HOME CARE EAR EXAMINATIO KIT | Home Care Instruments, Inc. | 1994-11-08 |
| K943731 | VIDEO OTOSCOPE | Cuda Products Co. | 1994-10-11 |
| K944031 | VIDEO SCOPE SYSTEM (OTOSCOPE) | Jedmed Instrument Co. | 1994-09-23 |
| K943916 | VIDEOTOSCOPE | Welch Allyn, Inc. | 1994-08-25 |
| K942244 | REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE | National Custom Ent., Inc. | 1994-06-24 |
| K941659 | AURAL-CAM, VIDEO EAR, VID RX | Gracefully Yours, Inc. | 1994-04-26 |
| K932259 | CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE | Clarus Medical Systems, Inc. | 1993-12-15 |
| K925752 | STANDARD | Rudolf Riester GmbH & Co. KG | 1993-10-08 |
| K925753 | UNI III | Rudolf Riester GmbH & Co. KG | 1993-10-08 |
| K932503 | RI-MINI | Rudolf Riester GmbH & Co. KG | 1993-10-08 |
| K932505 | RI-STAR | Rudolf Riester GmbH & Co. KG | 1993-10-08 |
| K932506 | RI-SCOPE (S) | Rudolf Riester GmbH & Co. KG | 1993-10-08 |
| K925758 | OTOSCOPE | Rudolf Riester GmbH & Co. KG | 1993-08-03 |
| K925759 | UNI I | Rudolf Riester GmbH & Co. KG | 1993-07-26 |
| K923830 | XOMED-TREACE ALPHASCOPE | Xomed-Treace, Inc. | 1992-11-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 16972545090031 | Jeashia | Zhejiang Honsun Medical Technology Co., Ltd. | 2026-05-18 |
| 16972545090017 | Jeashia | Zhejiang Honsun Medical Technology Co., Ltd. | 2026-05-18 |
| 00050428029497 | CVS | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 2026-02-13 |
| KTS0025716 | K.T.Surgico | K.T.SURGICO | 2024-07-24 |
| 00311917035000 | Walgreens | WALGREEN CO. | 2023-11-01 |
| 20884392954455 | Safety 1st | DOREL JUVENILE GROUP, INC. | 2023-10-15 |
| 10884389104514 | Medline | MEDLINE INDUSTRIES, INC. | 2023-01-21 |
| 10884389104521 | Medline | MEDLINE INDUSTRIES, INC. | 2023-01-21 |
| 27290018446151 | Nonagon N9+ SmartExam | NONAGON LTD | 2022-09-28 |
| 17290018446154 | Nonagon N9+ | NONAGON LTD | 2022-09-28 |
| M368122711 | LABTRON | GF HEALTH PRODUCTS, INC. | 2020-09-15 |
| H65811255281 | Henry Schein | HENRY SCHEIN, INC. | 2020-06-16 |
| H65811255271 | Henry Schein | HENRY SCHEIN, INC. | 2020-06-16 |
| 10304040029203 | Henry Schein | HENRY SCHEIN, INC. | 2018-12-21 |
| 10304040029197 | Henry Schein | HENRY SCHEIN, INC. | 2018-09-24 |
| 10381780403869 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-08-16 |
| 10381780403289 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-08-16 |
| 10381780403234 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-08-16 |
| 10381780479369 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-08-16 |
| 00634782048754 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782048747 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782048693 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782048686 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782047689 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782036232 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782032944 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782032869 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782032654 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782032494 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |
| 00634782032425 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |