Product code QJG
- Device name
- Device System, Imaging, Tympanic Membrane And Middle Ear
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1560
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Is intended for use as an imaging tool for visualization of the human tympanic membrane and middle ear space.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K222655 | OtoSight Middle Ear Scope | Photonicare, Inc. | 2022-09-26 |
| K191804 | TOMi Scope | Photonicare, Inc. | 2019-12-05 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00850013784134 | OtoSight Middle Ear Scope with Battery | Photonicare, Inc. | 2023-08-20 |
| 00850013784004 | OtoSight Middle Ear Scope | Photonicare, Inc. | 2022-04-15 |
| 00850013784110 | OtoSight Speculum Tip Combination Package | Photonicare, Inc. | 2022-04-15 |
| 00850013784097 | Large OtoSight Speculum Tip QTY 20 | Photonicare, Inc. | 2022-04-15 |
| 10850013784087 | Standard Otosight Speculum Tip QTY 20 | Photonicare, Inc. | 2022-04-15 |