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 | K122267 |
510k Number | K122267 |
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 Anthony |
Correspondent | Agata Anthony 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 | 2012-07-30 |
Decision Date | 2012-10-02 |
Summary: | summary |