The following data is part of a premarket notification filed by Visicu, Inc. with the FDA for Argus System-continuous Expert Care Network.
Device ID | K001972 |
510k Number | K001972 |
Device Name: | ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK |
Classification | System, Network And Communication, Physiological Monitors |
Applicant | VISICU, INC. 21911 ERIE LN. Lake Forest, CA 92630 |
Contact | Carol Patterson |
Correspondent | Carol Patterson VISICU, INC. 21911 ERIE LN. Lake Forest, CA 92630 |
Product Code | MSX |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-28 |
Decision Date | 2000-10-27 |