REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K072996
Device Name REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM
Applicant
RESPIRONICS, INC.
1740 golden mile highway
monroeville, 
PA 
15146

Applicant Contact zita a yurko
Correspondent
RESPIRONICS, INC.
1740 golden mile highway
monroeville, 
PA 
15146

Correspodent Contact zita a yurko
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 10/24/2007
Decision Date 12/27/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls