The following data is part of a premarket notification filed by Maybe?mom with the FDA for Maybe?mom Mini Ovulation Microscope.
| Device ID | K013582 |
| 510k Number | K013582 |
| Device Name: | MAYBE?MOM MINI OVULATION MICROSCOPE |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | MAYBE?MOM 22 CHURCH ST. SUITE 103-244 Ramsey, NJ 07446 |
| Contact | Toni Millerva |
| Correspondent | Toni Millerva MAYBE?MOM 22 CHURCH ST. SUITE 103-244 Ramsey, NJ 07446 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-30 |
| Decision Date | 2003-01-16 |
| Summary: | summary |