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FDA 510(k), K191804, TOMi Scope
FDA 510(k), K191804, TOMi Scope
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510(K) Number: K191804
Device Name: TOMi Scope
Manufacturer: PhotoniCare, Inc.
Device Classification Name: Device System, Imaging, Tympanic Membrane And Middle Ear
Regulation Number: 892.1560
Classification Product Code: QJG
Date Received: 07/05/2019
Decision Date: 12/05/2019
Regulation Medical Specialty: Radiology
Device Name: TOMi Scope
Manufacturer: PhotoniCare, Inc.
Device Classification Name: Device System, Imaging, Tympanic Membrane And Middle Ear
Regulation Number: 892.1560
Classification Product Code: QJG
Date Received: 07/05/2019
Decision Date: 12/05/2019
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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