Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K082704
Device Classification Name
System, Monitoring, For Progress Of Labor
More FDA Info for this Device
510(K) Number
K082704
Device Name
System, Monitoring, For Progress Of Labor
Applicant
BARNEV, LTD.
20 HATA'AS ST.
KFAR SABA 44425 IL
Other 510(k) Applications for this Company
Contact
AHAVA STEIN
Other 510(k) Applications for this Contact
Regulation Number
884.2800
More FDA Info for this Regulation Number
Classification Product Code
NPB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/16/2008
Decision Date
01/09/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact