ACCUSOM


Device Classification Name

ventilatory effort recorder

510(k) Number K110486
Device Name ACCUSOM
Applicant
NOVASOM, INC.
801 cromwell park drive
glen burnie, 
MD 
21061

Applicant Contact roger k richardson
Correspondent
NOVASOM, INC.
801 cromwell park drive
glen burnie, 
MD 
21061

Correspodent Contact roger k richardson
Regulation Number 868.2375
Classification Product Code
MNR  
Date Received 02/22/2011
Decision Date 08/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No