MODIFICATION TO NASAL-AIRE


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K022465
Device Name MODIFICATION TO NASAL-AIRE
Original Applicant
INNOMED TECHNOLOGIES
506 garden street
greensburg, 
PA 
15601

Original Contact marge walls-walker
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 07/26/2002
Decision Date 03/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No