PAPILLON MASK SET


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K023068
Device Name PAPILLON MASK SET
Original Applicant
MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH
14040 danielson st.
poway, 
CA 
92064

Original Contact roger kotter
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 09/16/2002
Decision Date 05/28/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No