The following data is part of a premarket notification filed by Siemens Life Support Systems with the FDA for Cav 3.0c Software Program.
Device ID | K890932 |
510k Number | K890932 |
Device Name: | CAV 3.0C SOFTWARE PROGRAM |
Classification | Spirometer, Monitoring (w/wo Alarm) |
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 | BZK |
CFR Regulation Number | 868.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-24 |
Decision Date | 1989-06-12 |