Device Type ID | 118 |
Device Name | Bed, Rocking, Breathing Assist |
Regulation Description | Rocking Bed. |
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) Respiratory Devices Branch (RPDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 868.5180 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | CCO |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | Yes |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
Device Type ID | 118 |
Device | Bed, Rocking, Breathing Assist |
Product Code | CCO |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Rocking Bed. |
CFR Regulation Number | 868.5180 [🔎] |