The following data is part of a premarket notification filed by Steris with the FDA for Amsco 600 Steam Sterilizer, V-pro Max 2 Low Temperature Sterilization System, V-pro S2 Low Temperature Sterilization System, Ras 12 Rack, Ras 12 Long Rack, Ras Cycle Of The Amsco 7052hp And 7053hp Single Chamber Washer Disinfector.
| Device ID | K222543 |
| 510k Number | K222543 |
| Device Name: | AMSCO 600 Steam Sterilizer, V-PRO MaX 2 Low Temperature Sterilization System, V-PRO S2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle Of The AMSCO 7052HP And 7053HP Single Chamber Washer Disinfector |
| Classification | Washer, Cleaner, Automated, Endoscope |
| Applicant | Steris 5960 Heisley Rd Mentor, OH 44060 |
| Contact | Anthony Piotrkowski |
| Correspondent | Anthony Piotrkowski Steris 5960 Heisley Rd Mentor, OH 44060 |
| Product Code | NVE |
| Subsequent Product Code | FLE |
| Subsequent Product Code | MLR |
| Subsequent Product Code | PEC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-22 |
| Decision Date | 2022-08-25 |