The following data is part of a premarket notification filed by Steris Corporation with the FDA for V-pro Max 2 Low Temperature Sterilization System, V-pro Max Low Temperature Sterilization System, V-pro 1 Plus Low Temperature Sterilization System, V-pro 1 Low Temperature Sterilization System.
| Device ID | K190103 |
| 510k Number | K190103 |
| Device Name: | V-PRO MaX 2 Low Temperature Sterilization System, V-PRO MaX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System |
| Classification | Sterilizer, Chemical |
| Applicant | STERIS Corporation 5960 Heisley Rd Mentor, OH 44060 |
| Contact | Anthony Piotrkowski |
| Correspondent | Anthony Piotrkowski STERIS Corporation 5960 Heisley Rd Mentor, OH 44060 |
| Product Code | MLR |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-22 |
| Decision Date | 2019-04-05 |