NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM


Device Classification Name

electrode measurement, blood-gases (pco2, po2) and blood ph

510(k) Number K110648
Device Name NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
Applicant
NOVA BIOMEDICAL CORPORATION
200 prospect st.
waltham, 
MA 
02453

Applicant Contact paul w macdonald
Correspondent
NOVA BIOMEDICAL CORPORATION
200 prospect st.
waltham, 
MA 
02453

Correspodent Contact paul w macdonald
Regulation Number 862.1120
Classification Product Code
CHL  
Subsequent Product Codes
BXX   CDS   CEM   CFA   CGA  
CGL   CGZ   GGZ   GHS   GJC   GKK  
GLY   JFP   JGS   JIX   JJB   NGD  
Date Received 03/04/2011
Decision Date 08/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No