510(k) K222552
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) by
Stryker Instruments
— Product Code JCX
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2022
- Date Received
- August 23, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type