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FDA 510(k) Application Details - K162478
Device Classification Name
More FDA Info for this Device
510(K) Number
K162478
Device Name
ivWatch
Applicant
ivWatch, LLC
1100 Exploration Way, Suite 209
Hampton, VA 23666 US
Other 510(k) Applications for this Company
Contact
Jaclyn Lautz
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PMS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/06/2016
Decision Date
12/22/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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