| Device Type ID | 102 |
| Device Name | Apparatus, Gas-scavenging |
| Regulation Description | Gas-scavenging Apparatus. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.5430 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CBN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 102 |
| Device | Apparatus, Gas-scavenging |
| Product Code | CBN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gas-scavenging Apparatus. |
| CFR Regulation Number | 868.5430 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SEDATION SYSTEMS LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELEFLEX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TELEFLEX MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 1 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Maquet Cardiovascular Us Sales, Llc | II | Feb-27-2015 |