| Device Type ID | 2561 |
| Device Name | Incubator, Neonatal |
| Regulation Description | Neonatal Incubator. |
| 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) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FMZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2561 |
| Device | Incubator, Neonatal |
| Product Code | FMZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Neonatal Incubator. |
| CFR Regulation Number | 880.5400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BISTOS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DRAEGER MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DRAEGER MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DRAEGERWERK AG & CO. KGAA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DRAGERWERK AG & CO. KGAA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Contamination During Use | 6 |
Appropriate Term/Code Not Available | 3 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Loss Of Or Failure To Bond | 1 |
Use Of Device Problem | 1 |
Patient Device Interaction Problem | 1 |
Mechanical Problem | 1 |
Insufficient Information | 1 |
| Total Device Problems | 16 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | GE Healthcare, LLC | II | Nov-19-2018 |
| 2 | Natus Medical Incorporated | II | Oct-07-2016 |
| 3 | Natus Medical Incorporated | II | Apr-11-2016 |
| 4 | Ohmeda Medical | II | Mar-20-2017 |