Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K210160
Device Classification Name
System,Network And Communication,Physiological Monitors
More FDA Info for this Device
510(K) Number
K210160
Device Name
System,Network And Communication,Physiological Monitors
Applicant
AlertWatch, Inc.
330 East Liberty St., Fourth Floor
Ann Arbor, MI 48104 US
Other 510(k) Applications for this Company
Contact
Justin Adams
Other 510(k) Applications for this Contact
Regulation Number
870.2300
More FDA Info for this Regulation Number
Classification Product Code
MSX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/21/2021
Decision Date
09/10/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact