Food and Drug Administration

Obstetrics and Gynecology Devices Panel

June 23, 2005

Neoventa STAN® S31 Fetal Heart Monitoring System (P020001)

Briefing Information

FDA Draft Presentation (PDF)

FDA Executive Summary (PDF)

Disclaimer

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.

Classification of FHR Patterns (PDF)

User Manual (PDF)

Bibliography (PDF)

Summary of Safety and Effectiveness (PDF)

Fetal Surveillance Traning Textbook (PDF)