The following data is part of a premarket notification filed by Stryker Instruments with the FDA for 120v Neptune S Rover (0711-001-000);v2 4-port Manifold (0750-400-000);v2 Specimen Collection Manifold Kit (0750-200-000);v2 Specimen Collection Tray (0750-210-000).
| Device ID | K222552 |
| 510k Number | K222552 |
| Device Name: | 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000) |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | Stryker Instruments 1941 Stryker Way Portage, MI 49002 |
| Contact | Tu Nguyen |
| Correspondent | Tu Nguyen Stryker Instruments 1941 Stryker Way Portage, MI 49002 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-23 |
| Decision Date | 2022-12-09 |