OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER


Device Classification Name

holding chambers, direct patient interface

510(k) Number K110293
Device Name OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER
Applicant
RESPIRONICS NEW JERSEY, INC.
5 wood hollow road
parsippany, 
NJ 
07054

Applicant Contact lauren ziegler
Correspondent
RESPIRONICS NEW JERSEY, INC.
5 wood hollow road
parsippany, 
NJ 
07054

Correspodent Contact lauren ziegler
Regulation Number 868.5630
Classification Product Code
NVP  
Date Received 02/01/2011
Decision Date 08/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No