The following data is part of a premarket notification filed by Ningbo David Medical Device Co.,ltd with the FDA for Infant Incubator.
| Device ID | K190494 |
| 510k Number | K190494 |
| Device Name: | Infant Incubator |
| Classification | Incubator, Neonatal |
| Applicant | Ningbo David Medical Device Co.,Ltd No.2, Keyuan Road, Shipu Technology Park, Xiangshan Ningbo, CN 315731 |
| Contact | Lin Dingyu |
| Correspondent | Lin Dingyu Ningbo David Medical Device Co.,Ltd No.2, Keyuan Road, Shipu Technology Park, Xiangshan Ningbo, CN 315731 |
| Product Code | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-28 |
| Decision Date | 2019-11-25 |
| Summary: | summary |