The following data is part of a premarket notification filed by Cambridge Temperature Concepts Ltd. with the FDA for Duofertility.
| Device ID | K102499 |
| 510k Number | K102499 |
| Device Name: | DUOFERTILITY |
| Classification | Device, Fertility Diagnostic, Proceptive |
| Applicant | CAMBRIDGE TEMPERATURE CONCEPTS LTD. P.O. BOX 390930 Cambridge, MA 02139 |
| Contact | Scott R Mackie |
| Correspondent | Scott R Mackie CAMBRIDGE TEMPERATURE CONCEPTS LTD. P.O. BOX 390930 Cambridge, MA 02139 |
| Product Code | LHD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-31 |
| Decision Date | 2011-12-20 |
| Summary: | summary |