7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K030822
Device Name 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV 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 868.5905
Classification Product Code
BZD  
Date Received 03/14/2003
Decision Date 06/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No