HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS


Device Classification Name

ventilator, continuous, facility use

510(k) Number K030515
Device Name HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS
Applicant
HANS RUDOLPH, INC.
7200 wyandotte
kansas city, 
MO 
64114

Applicant Contact kevin rudolph
Correspondent
HANS RUDOLPH, INC.
7200 wyandotte
kansas city, 
MO 
64114

Correspodent Contact kevin rudolph
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 02/19/2003
Decision Date 05/02/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No