The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Giraffe And Panda Warmers.
| Device ID | K123309 |
| 510k Number | K123309 |
| Device Name: | GIRAFFE AND PANDA WARMERS |
| Classification | Warmer, Infant Radiant |
| Applicant | OHMEDA MEDICAL 8880 GORMAN RD. Laurel, MD 20723 |
| Contact | Agata Anthony |
| Correspondent | Agata Anthony 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 | 2012-10-24 |
| Decision Date | 2013-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682103923 | K123309 | 000 |
| 00840682103916 | K123309 | 000 |
| 00840682103909 | K123309 | 000 |
| 00840682103893 | K123309 | 000 |
| 00195278358363 | K123309 | 000 |