PROFOX SOFTWARE, MODEL 920M-41

codes

Device Classification Name

oximeter

510(k) Number K001708
Device Name PROFOX SOFTWARE, MODEL 920M-41
Original Applicant
RESPIRONICS GEORGIA, INC.
1255 kennestone circle
marietta, 
GA 
30066

Original Contact gerry richardson
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 06/05/2000
Decision Date 03/01/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No