REMSTAR PRO WITH C-FLEX CPAP SYSTEM


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K021861
Device Name REMSTAR PRO WITH C-FLEX CPAP SYSTEM
Original Applicant
RESPIRONICS, INC.
1001 murry ridge ln.
murrysville, 
PA 
15668

Original Contact zita a yurko
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 06/06/2002
Decision Date 06/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No