Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K181077
Device Classification Name
Device, Sleep Assessment
More FDA Info for this Device
510(K) Number
K181077
Device Name
Device, Sleep Assessment
Applicant
ActiGraph
49 E Chase St
Pensacola, FL 32502 US
Other 510(k) Applications for this Company
Contact
Brian Bell
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LEL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/24/2018
Decision Date
05/24/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact