STARDUST II, MODEL 1011176


Device Classification Name

ventilatory effort recorder

510(k) Number K021845
Device Name STARDUST II, MODEL 1011176
Original Applicant
RESPIRONICS, INC.
1001 murry ridge ln.
murrysville, 
PA 
15668

Original Contact zita yurko
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 06/05/2002
Decision Date 05/20/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No