The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Servo Ventilator 900 C/d.
Device ID | K871354 |
510k Number | K871354 |
Device Name: | SERVO VENTILATOR 900 C/D |
Classification | Ventilator, Continuous, Facility Use |
Applicant | SIEMENS ELEMA AB 2360 NORTH PALMER DR. P.O. BOX 94517 Schaumburg, IL 60195 |
Contact | Ellen Farney |
Correspondent | Ellen Farney SIEMENS ELEMA AB 2360 NORTH PALMER DR. P.O. BOX 94517 Schaumburg, IL 60195 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-06 |
Decision Date | 1987-07-21 |