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FDA 510(k) Application Details - DEN200017
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN200017
Device Name
Q-Collar
Applicant
Q30 Sports Science, LLC
257 Riverside Avenue
Westport, CT 06880 US
Other 510(k) Applications for this Company
Contact
Gary A. Greene
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QNX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/19/2020
Decision Date
02/26/2021
Decision
DENG -
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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