NEUMOVENT GRAPHNET


Device Classification Name

ventilator, continuous, facility use

510(k) Number K111595
Device Name NEUMOVENT GRAPHNET
Applicant
TECME S.A.
79 brookline road
mason, 
NH 
03048

Applicant Contact ray kelly
Correspondent
TECME S.A.
79 brookline road
mason, 
NH 
03048

Correspodent Contact ray kelly
Regulation Number 868.5895
Classification Product Code
CBK  
Date Received 06/07/2011
Decision Date 01/27/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No