The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Ph-100, Model 2104.
| Device ID | K991346 |
| 510k Number | K991346 |
| Device Name: | PH-100, MODEL 2104 |
| Classification | Media, Reproductive |
| Applicant | VITROLIFE SWEDEN AB MOLNDALSVAGEN 30 Gothenburg, SE Se-412 63 |
| Contact | Eiler Anderson |
| Correspondent | Eiler Anderson VITROLIFE SWEDEN AB MOLNDALSVAGEN 30 Gothenburg, SE Se-412 63 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-19 |
| Decision Date | 2000-02-24 |
| Summary: | summary |