The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda Medical Omnibed.
Device ID | K993407 |
510k Number | K993407 |
Device Name: | OHMEDA MEDICAL OMNIBED |
Classification | Incubator, Neonatal |
Applicant | OHMEDA MEDICAL 9065 GUILFORD RD. Columbia, MD 21046 |
Contact | Alberto F Profumo |
Correspondent | Alberto F Profumo OHMEDA MEDICAL 9065 GUILFORD RD. Columbia, MD 21046 |
Product Code | FMZ |
CFR Regulation Number | 880.5400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-08 |
Decision Date | 2000-01-05 |
Summary: | summary |