PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST


Device Classification Name

spirometer, monitoring (w/wo alarm)

510(k) Number K103578
Device Name PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST
Applicant
RESPIRONICS NOVAMETRIX, LLC
5 technology drive
wallingford, 
CT 
06492

Applicant Contact kevin mader
Correspondent
RESPIRONICS NOVAMETRIX, LLC
5 technology drive
wallingford, 
CT 
06492

Correspodent Contact kevin mader
Regulation Number 868.1850
Classification Product Code
BZK  
Date Received 12/06/2010
Decision Date 06/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No