VRIICU SYSTEM


Device Classification Name

lung sound monitor

510(k) Number K073582
Device Name VRIICU SYSTEM
Applicant
DEEP BREEZE LTD.
2001 pennsylvania avenue nw
suite 950
washington, 
DC 
20006

Applicant Contact jeff baetz
Correspondent
DEEP BREEZE LTD.
2001 pennsylvania avenue nw
suite 950
washington, 
DC 
20006

Correspodent Contact jeff baetz
Regulation Number 870.1875
Classification Product Code
OCR  
Date Received 12/20/2007
Decision Date 10/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No