The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Giraffe And Panda Warmer.
Device ID | K070377 |
510k Number | K070377 |
Device Name: | GIRAFFE AND PANDA WARMER |
Classification | Warmer, Infant Radiant |
Applicant | OHMEDA MEDICAL 8880 GORMAN RD. Laurel, MD 20723 |
Contact | Agata Smieja |
Correspondent | Agata Smieja OHMEDA MEDICAL 8880 GORMAN RD. Laurel, MD 20723 |
Product Code | FMT |
CFR Regulation Number | 880.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-02-08 |
Decision Date | 2007-07-11 |
Summary: | summary |