The following data is part of a premarket notification filed by Reprobitech Corp. with the FDA for Ivitri Ez.
| Device ID | K162640 |
| 510k Number | K162640 |
| Device Name: | IVitri EZ |
| Classification | Labware, Assisted Reproduction |
| Applicant | REPROBITECH CORP. 27 HADDON RD New Hyde Park, NY 11040 |
| Contact | Huai L. Feng |
| Correspondent | Huai L. Feng REPROBITECH CORP. 42-31 Colden Street, Suite 202 Flushing, NY 11355 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-22 |
| Decision Date | 2017-06-30 |