The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Giraffe And Panda T- Piece Resuscitation System.
| Device ID | K070210 |
| 510k Number | K070210 |
| Device Name: | GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| 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 | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-22 |
| Decision Date | 2007-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682100151 | K070210 | 000 |