Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K112637
Device Classification Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K112637
Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant
NIHON KOHDEN
90 ICON
FOOTHILL RANCH, CA 92610 US
Other 510(k) Applications for this Company
Contact
STEVE GEERDES
Other 510(k) Applications for this Contact
Regulation Number
870.1025
More FDA Info for this Regulation Number
Classification Product Code
MHX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/09/2011
Decision Date
12/09/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact