Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K990569
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K990569
Device Name
System, Monitoring, Perinatal
Applicant
HUNTLEIGH HEALTHCARE, INC.
227 RT. 33 EAST
MANALAPAN, NJ 07726 US
Other 510(k) Applications for this Company
Contact
AUDREY A WITCO
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
02/23/1999
Decision Date
01/24/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
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