Product Classification

• Device: monitor, cardiac, fetal
• Regulation Description: Fetal cardiac monitor.
• Regulation Medical Specialty: Obstetrics/Gynecology
• Review Panel: Obstetrics/Gynecology
• Product Code: KXN
• Premarket Review: Reproductive, Gynecology and Urology Devices (DHT3B); Reproductive, Gynecology and Urology Devices (DHT3B)
• Submission Type: 510(k)
• Regulation Number: 884.2600
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• smo india
• third party review group, llc