The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Modification To: Ohmeda Medical Giraffe Incubator (giraffe And Panda Uninterruptible Power Supply).
| Device ID | K072512 |
| 510k Number | K072512 |
| Device Name: | MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) |
| Classification | Incubator, Neonatal |
| Applicant | DATEX-OHMEDA, INC. 8880 GORMAN ROAD Laurel, MD 20723 |
| Contact | Agata Smieja |
| Correspondent | Agata Smieja 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 | 2007-09-06 |
| Decision Date | 2007-10-03 |
| Summary: | summary |