OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K072418
Device Name OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER
Applicant
RESPIRONICS NEW JERSEY, INC.
41 canfield rd.
cedar grove, 
NJ 
07009

Applicant Contact lauren ziegler
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 08/28/2007
Decision Date 09/12/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

Yes