O_TWO CPAP SYSTEM


Device Classification Name

attachment, breathing, positive end expiratory pressure

510(k) Number K112546
Device Name O_TWO CPAP SYSTEM
Applicant
O-TWO MEDICAL TECHNOLOGIES, INC.
7575 kimbel st.
mississauga, ontario, 

CA

l5s 1c8

Applicant Contact ammar al-dojaily
Correspondent
O-TWO MEDICAL TECHNOLOGIES, INC.
7575 kimbel st.
mississauga, ontario, 

CA

l5s 1c8

Correspodent Contact ammar al-dojaily
Regulation Number 868.5965
Classification Product Code
BYE  
Date Received 09/01/2011
Decision Date 12/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No