510(k) K191804
K191804 is an FDA 510(k) premarket notification submitted by Photonicare, Inc. for the device "TOMi Scope". The FDA issued a decision of Substantially Equivalent on Dec 5, 2019. The device falls under product code QJG (Device System, Imaging, Tympanic Membrane And Middle Ear), a Class II device regulated under 21 CFR 892.1560. Photonicare, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 5, 2019
- Date Received
- Jul 5, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device System, Imaging, Tympanic Membrane And Middle Ear
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- EN
- Submission Type
- 510(k)
Is intended for use as an imaging tool for visualization of the human tympanic membrane and middle ear space.