The following data is part of a premarket notification filed by Ohmeda Medical, A Division Of Datex-ohmeda, Inc., with the FDA for Giraffe And Panda Warmers.
| Device ID | K101804 |
| 510k Number | K101804 |
| Device Name: | GIRAFFE AND PANDA WARMERS |
| Classification | Warmer, Infant Radiant |
| Applicant | OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC., 8880 GORMAN RD. Laurel, MD 20723 |
| Contact | Agata Smieja |
| Correspondent | Agata Smieja OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC., 8880 GORMAN RD. Laurel, MD 20723 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-28 |
| Decision Date | 2010-07-21 |
| Summary: | summary |