QUIXIE NEBULIZER


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K112564
Device Name QUIXIE NEBULIZER
Applicant
ODYSSEY MEDICAL TECHNOLOGIES
4807 el camino ave,
suite c
carmichael, 
CA 
95608

Applicant Contact david piper
Correspondent
ODYSSEY MEDICAL TECHNOLOGIES
4807 el camino ave,
suite c
carmichael, 
CA 
95608

Correspodent Contact david piper
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 09/02/2011
Decision Date 11/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No