The following data is part of a premarket notification filed by Maquet Critical Care Ab with the FDA for Servo-i Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585.
Device ID | K073179 |
510k Number | K073179 |
Device Name: | SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585 |
Classification | Ventilator, Continuous, Facility Use |
Applicant | MAQUET CRITICAL CARE AB 1140 ROUTE 22 EAST SUITE 202 Bridgewater, NJ 08807 |
Contact | Jamie Yieh |
Correspondent | Jamie Yieh MAQUET CRITICAL CARE AB 1140 ROUTE 22 EAST SUITE 202 Bridgewater, NJ 08807 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-13 |
Decision Date | 2008-06-09 |
Summary: | summary |