510(k) K191804
- Device
- TOMi Scope
- Applicant
- PhotoniCare, Inc.
- 510(k) number
- K191804
- Product code
- QJG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-12-05
- Date received
- 2019-07-05
- Regulation
- 892.1560
- Classification name
- Device System, Imaging, Tympanic Membrane And Middle Ear
- Medical specialty
- Radiology
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ryan Shelton
- Address
- 60 Hazelwood Dr. 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 |
|---|---|---|---|
| K222655 | OtoSight Middle Ear Scope | Photonicare, Inc. | 2022-09-26 |
Legacy Summary#
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FDA Review#
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