K191804 is an FDA 510(k) clearance for the TOMi Scope. This device is classified as a Device System, Imaging, Tympanic Membrane And Middle Ear (Class II - Special Controls, product code QJG).
Submitted by Photonicare, Inc. (Champaign, US). The FDA issued a Cleared decision on December 5, 2019, 153 days after receiving the submission on July 5, 2019.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 892.1560. Is Intended For Use As An Imaging Tool For Visualization Of The Human Tympanic Membrane And Middle Ear Space..
| 510(k) Number | K191804 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2019 |
| Decision Date | December 05, 2019 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | QJG - Device System, Imaging, Tympanic Membrane And Middle Ear |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |
| Definition | Is Intended For Use As An Imaging Tool For Visualization Of The Human Tympanic Membrane And Middle Ear Space. |