The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Advent Ventilator.
Device ID | K884793 |
510k Number | K884793 |
Device Name: | ADVENT VENTILATOR |
Classification | Ventilator, Continuous, Facility Use |
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 | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-16 |
Decision Date | 1989-06-12 |