ZI BLOWER


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K121374
Device Name ZI BLOWER
Applicant
DESHUM MEDICAL
5 timber lane
north reading, 
MA 
01864

Applicant Contact maureen o’connell
Correspondent
DESHUM MEDICAL
5 timber lane
north reading, 
MA 
01864

Correspodent Contact maureen o’connell
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 05/07/2012
Decision Date 02/22/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No