The following data is part of a premarket notification filed by Ohmeda Medical, A Division Of Datex-ohmeda, Inc. with the FDA for Giraffe Incubator Carestation Cs1.
| Device ID | K152809 |
| 510k Number | K152809 |
| Device Name: | Giraffe Incubator Carestation CS1 |
| Classification | Incubator, Neonatal |
| Applicant | OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC. 8880 GORMAN ROAD Laurel, MD 20723 |
| Contact | Kenny Bello |
| Correspondent | Kenny Bello OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC. 8880 GORMAN ROAD Laurel, MD 20723 |
| Product Code | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-28 |
| Decision Date | 2015-12-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682116855 | K152809 | 000 |