VISI MOBILE MONITORING SYSTEM


Device Classification Name

monitor,physiological,patient(without arrhythmia detection or alarms)

510(k) Number K112478
Device Name VISI MOBILE MONITORING SYSTEM
Applicant
SOTERA WIRELESS, INC
9444 waples street
san diego, 
CA 
92121

Applicant Contact eben gordon
Correspondent
SOTERA WIRELESS, INC
9444 waples street
san diego, 
CA 
92121

Correspodent Contact eben gordon
Regulation Number 870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DQA   DRT   DXN   FLL  
Date Received 08/29/2011
Decision Date 03/22/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Clinical Trials NCT00881829
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls