The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Rapidvit™ Oocyte, Rapidwarm™ Oocyte.
| Device ID | K183486 |
| 510k Number | K183486 |
| Device Name: | RapidVit™ Oocyte, RapidWarm™ Oocyte |
| Classification | Media, Reproductive |
| Applicant | Vitrolife Sweden AB Gustaf Werners Gata 2 Vastra Frolunda, SE 421 32 |
| Contact | Nina Arvidsson |
| Correspondent | Nina Arvidsson Vitrolife Sweden AB Gustaf Werners Gata 2 Vastra Frolunda, SE 421 32 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-17 |
| Decision Date | 2019-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350025914817 | K183486 | 000 |
| 07350025914800 | K183486 | 000 |