STAT PROFILE PHOX PLUS C ANALYZER


Device Classification Name

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

510(k) Number K021713
Device Name STAT PROFILE PHOX PLUS C ANALYZER
Original Applicant
NOVA BIOMEDICAL CORP.
200 prospect st.
waltham, 
MA 
02454 -9141

Original Contact paul w macdonald
Regulation Number 862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   GKR   JEP  
JGS   JIX   JKS   JPI   JPK  
Date Received 05/23/2002
Decision Date 07/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No