The following data is part of a premarket notification filed by Draeger Medical Sytems, Inc. with the FDA for Isolette 8000 Plus.
| Device ID | K172154 |
| 510k Number | K172154 |
| Device Name: | Isolette 8000 Plus |
| Classification | Incubator, Neonatal |
| Applicant | Draeger Medical Sytems, Inc. 3135 Quarry Road Telford, PA 18969 |
| Contact | Gale Winarsky |
| Correspondent | Gale Winarsky Draeger Medical Sytems, Inc. 3135 Quarry Road Telford, PA 18969 |
| Product Code | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-17 |
| Decision Date | 2018-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049098090612 | K172154 | 000 |