The following data is part of a premarket notification filed by Sotera Wireless, Inc. with the FDA for Visi Mobile Monitoring System.
Device ID | K150361 |
510k Number | K150361 |
Device Name: | ViSi Mobile Monitoring System |
Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
Applicant | Sotera Wireless, Inc. 10020 Huennekens Street San Diego, CA 92121 |
Contact | Carson Krupp |
Correspondent | Carson Krupp Sotera Wireless, Inc. 10020 Huennekens Street San Diego, CA 92121 |
Product Code | MWI |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-12 |
Decision Date | 2015-04-30 |
Summary: | summary |