Definition: The Liquid Chemical Processing System Is Intended As A Standard Method For Routine Monitoring.
| Device Type ID | 2731 |
| Device Name | Liquid Chemical Processing System |
| Physical State | The Liquid Chemical Processing Monitor Consists Of A Filter Paper-based Carrier (¼ In X 1⅜ In) Inoculated With G. Stearothermophilus 7953 Spores And Packaged In A Glassine Envelope, A Vial Containing 5 Ml Of Modified Trypticase Soy Broth With T |
| Technical Method | The Device Is Placed In The System With The Load. During The Processing Cycle, The Liquid Chemical Processing Monitor Is Exposed To The Liquid Chemical. Some Of The Spores On The Strip Will Be Killed And And Some Of The Spores Will Be Physically Wash |
| Target Area | This Device Is Has No Patient Contact. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Infection Control Devices Branch (INCB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.6887 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OVY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2731 |
| Device | Liquid Chemical Processing System |
| Product Code | OVY |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 880.6887 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
STERIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |