The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda Auxiliary Power System.
Device ID | K863208 |
510k Number | K863208 |
Device Name: | OHMEDA AUXILIARY POWER SYSTEM |
Classification | Warmer, Infant Radiant |
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 | FMT |
CFR Regulation Number | 880.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-08-19 |
Decision Date | 1986-10-03 |