Food and Drug Administration
Obstetrics and Gynecology Devices Panel
April 22, 2002
Neoventa STAN S21 Fetal Heart Monitor (P020001)
Sponsor - Neoventa, Inc.
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
Cover Letter - Introduction pdf
Bibliographic Listing pdf
Summary of Safety and Effectiveness pdf
Device Description pdf
Swedish Randomized Controlled Trial (RCT), Revised 02/18/02 pdf
Swedish Randomized Controlled Trial (RCT), Final Version, 05/05/98 pdf
Neonatal outcome in the CTG group pdf
Neonatal outcome in the CTG+ST group pdf
Cases of metabolic acidosis in CTG group not requiring special neonatal care - ST information revealed pdf
Cases of metabolic acidosis in CTG_ST group not requiring special neonatal case pdf
Dissemination of Knowledge, Centers of Excellance Program pdf
Summary of the STANŽ S 21 clinical database - data from the city of Gothenburg pdf
Summary Chart of Prior Clinical Studies pdf
Note: This brief package contained copyrighted material which may be view at: Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.