Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K042082
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K042082
Device Name
System, Monitoring, Perinatal
Applicant
MP4 SOLUTIONS, LP
11 LYNN BATTS LANE
SAN ANTONIO, TX 78218 US
Other 510(k) Applications for this Company
Contact
WILLIAM CAMERON POWELL
Other 510(k) Applications for this Contact
Regulation Number
884.2740
More FDA Info for this Regulation Number
Classification Product Code
HGM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/03/2004
Decision Date
01/21/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact