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FDA 510(k) Application Details - K191804
Device Classification Name
More FDA Info for this Device
510(K) Number
K191804
Device Name
TOMi Scope
Applicant
PhotoniCare, Inc.
60 Hazelwood Dr.
Champaign, IL 61820 US
Other 510(k) Applications for this Company
Contact
Ryan Shelton
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QJG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/05/2019
Decision Date
12/05/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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