REUSABLE HEADREST WITH NASAL SEAL


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K072993
Device Name REUSABLE HEADREST WITH NASAL SEAL
Applicant
AEIOMED, INC.
800 levanger lane
stoughton, 
WI 
53589

Applicant Contact gary syring
Correspondent
AEIOMED, INC.
800 levanger lane
stoughton, 
WI 
53589

Correspodent Contact gary syring
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 10/23/2007
Decision Date 02/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No