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 |