The following data is part of a premarket notification filed by Siemens Life Support Systems with the FDA for Servo Ventilator 300.
Device ID | K902859 |
510k Number | K902859 |
Device Name: | SERVO VENTILATOR 300 |
Classification | Ventilator, Continuous, Facility Use |
Applicant | SIEMENS LIFE SUPPORT SYSTEMS 2360 N. PALMER DR. Schaumburg, IL 60173 |
Contact | Ellen Farney |
Correspondent | Ellen Farney SIEMENS LIFE SUPPORT SYSTEMS 2360 N. PALMER DR. Schaumburg, IL 60173 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-29 |
Decision Date | 1991-04-26 |