The following data is part of a premarket notification filed by Siemens Life Support Systems with the FDA for Data Exchange System, Model 24.
Device ID | K890921 |
510k Number | K890921 |
Device Name: | DATA EXCHANGE SYSTEM, MODEL 24 |
Classification | Ventilator, Continuous, Facility Use |
Applicant | SIEMENS LIFE SUPPORT SYSTEMS P.O. BOX 68517 Schaumberg, IL 60168 |
Contact | Ellen Farney |
Correspondent | Ellen Farney SIEMENS LIFE SUPPORT SYSTEMS P.O. BOX 68517 Schaumberg, IL 60168 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-24 |
Decision Date | 1989-06-08 |