The following data is part of a premarket notification filed by Hewlett-packard Gmbh with the FDA for Hp Viridia Component Monitoring System, Hp Viridia Cms 24/26, Model Rev. K With Easi-ecg Option.
Device ID | K990476 |
510k Number | K990476 |
Device Name: | HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTION |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | HEWLETT-PACKARD GMBH HERRENBERGER STR. 110-140 Boeblingen, DE 71034 |
Contact | Egon Pfeil |
Correspondent | Egon Pfeil HEWLETT-PACKARD GMBH HERRENBERGER STR. 110-140 Boeblingen, DE 71034 |
Product Code | MHX |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-02-16 |
Decision Date | 1999-07-22 |
Summary: | summary |