The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda - Logic 07a Transport Ventilator.
Device ID | K901846 |
510k Number | K901846 |
Device Name: | OHMEDA - LOGIC 07A TRANSPORT VENTILATOR |
Classification | Ventilator, Emergency, Powered (resuscitator) |
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 | BTL |
CFR Regulation Number | 868.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-24 |
Decision Date | 1990-08-08 |