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FDA 510(k) Application Details - K222212
Device Classification Name
More FDA Info for this Device
510(K) Number
K222212
Device Name
ivWatch Model 400
Applicant
ivWatch, LLC
700 Tech Center Parkway, Suite 300
Newport News, VA 23606 US
Other 510(k) Applications for this Company
Contact
Holly Novak
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Regulation Number
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Classification Product Code
PMS
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More FDA Info for this Product Code
Date Received
07/25/2022
Decision Date
08/24/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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