MORPHEUS OX


Device Classification Name

ventilatory effort recorder

510(k) Number K111314
Device Name MORPHEUS OX
Applicant
WIDEMED LTD
10, ha’sadnaot st.
herzliya, 

IL

46733

Applicant Contact john smith
Correspondent
WIDEMED LTD
10, ha’sadnaot st.
herzliya, 

IL

46733

Correspodent Contact john smith
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 05/10/2011
Decision Date 08/31/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No