510(k) K222655
- Device
- OtoSight Middle Ear Scope
- Applicant
- Photonicare, Inc.
- 510(k) number
- K222655
- Product code
- QJG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-09-26
- Date received
- 2022-09-02
- Regulation
- 892.1560
- Classification name
- Device System, Imaging, Tympanic Membrane And Middle Ear
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Ryan Shelton
- Address
- 1902 Fox Dr. Suite F Champaign IL US 61820 61820
FDA Registration Numbers
- 1000261180
- 3016597890
Source Documents
Other 510(k) Records For Product Code QJG
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191804 | TOMi Scope | Photonicare, Inc. | 2019-12-05 |