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U.S. Department of Health and Human Services

Product Classification

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Device device, fertility diagnostic, contraceptive, software application
Regulation Description Software application for contraception.
Definition Designed to monitor and provide fertility information to prevent pregnancy (contraception).
Physical State Software application, the physical platform may vary (e.g., mobile phone, PC, tablet, etc…)
Technical Method Algorithm transforms user data into user-specific information regarding fertility and provides timeframes when pregnancy is unlikely.
Target Area Not Applicable
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodePYT
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 884.5370
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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