The following data is part of a premarket notification filed by Schiller Ag with the FDA for Monitoring System, Model Argus Pb-2200.
Device ID | K033738 |
510k Number | K033738 |
Device Name: | MONITORING SYSTEM, MODEL ARGUS PB-2200 |
Classification | Computer, Blood-pressure |
Applicant | SCHILLER AG ALTGASSE 68 Baar, CH Ch-6341 |
Contact | Markus Buetler |
Correspondent | Markus Buetler SCHILLER AG ALTGASSE 68 Baar, CH Ch-6341 |
Product Code | DSK |
CFR Regulation Number | 870.1110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-11-28 |
Decision Date | 2004-08-24 |
Summary: | summary |