Device Type ID | 3 |
Device Name | Cabinet, Table And Tray, Anesthesia |
Regulation Description | Anesthetic Cabinet, Table, Or Tray. |
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) Exempt |
CFR Regulation Number | 868.6100 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | BRY |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3 |
Device | Cabinet, Table And Tray, Anesthesia |
Product Code | BRY |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Anesthetic Cabinet, Table, Or Tray. |
CFR Regulation Number | 868.6100 [🔎] |
Device Problems | |
---|---|
No Apparent Adverse Event | 9 |
Mechanical Problem | 2 |
Overheating Of Device | 1 |
Material Separation | 1 |
Patient Device Interaction Problem | 1 |
Material Frayed | 1 |
Device Inoperable | 1 |
Power Problem | 1 |
Device Operational Issue | 1 |
Total Device Problems | 18 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | B. Braun Medical, Inc. | II | May-04-2015 |
2 | CareFusion 303, Inc. | II | Feb-16-2016 |
3 | Stryker Communications | II | Jul-15-2014 |