ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)


Device Classification Name

plethysmograph, impedance

510(k) Number K112830
Device Name ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)
Applicant
NONINVASIVE MEDICAL TECHNOLOGIES, INC.
6412 s. arville street
las vegas, 
NV 
89118

Applicant Contact marc o’griofa
Correspondent
NONINVASIVE MEDICAL TECHNOLOGIES, INC.
6412 s. arville street
las vegas, 
NV 
89118

Correspodent Contact marc o’griofa
Regulation Number 870.2770
Classification Product Code
DSB  
Date Received 09/28/2011
Decision Date 11/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No