Definition: Intended For Medical Purposes Designed For The Use Of A Pediatric Patient Made Of All Construction Materials Used In A Hospital Nursery.
| Device Type ID | 2703 |
| Device Name | Bassinet, Hospital |
| Physical State | Bassinett |
| Technical Method | Made Of All Construction Materials |
| Target Area | Pediatric |
| Regulation Description | Pediatric Medical Crib. |
| 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) Exempt |
| CFR Regulation Number | 880.5140 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NZG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2703 |
| Device | Bassinet, Hospital |
| Product Code | NZG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Pediatric Medical Crib. |
| CFR Regulation Number | 880.5140 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Stryker Medical Division Of Stryker Corporation | II | Feb-07-2019 |