PEGASUS NASAL CPAP SYSTEM


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K022192
Device Name PEGASUS NASAL CPAP SYSTEM
Original Applicant
SENSORMEDICS CORP.
22705 savi ranch pkwy.
yorba linda, 
CA 
92887 -4645

Original Contact paul l kittinger
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 07/05/2002
Decision Date 01/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No