Definition: Designed To Monitor And Provide Fertility Information To Prevent Pregnancy (contraception).
| Device Type ID | 4103 |
| Device Name | Device, Fertility Diagnostic, Contraceptive, Software Application |
| 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 |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.5370 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PYT |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4103 |
| Device | Device, Fertility Diagnostic, Contraceptive, Software Application |
| Product Code | PYT |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 884.5370 [🔎] |