SPIRO PD


Device Classification Name

spirometer, diagnostic

510(k) Number K103575
Device Name SPIRO PD
Applicant
PMD HEALTHCARE
1468 harwell ave.
crofton, 
MD 
21114

Applicant Contact e.j. smith
Correspondent
PMD HEALTHCARE
1468 harwell ave.
crofton, 
MD 
21114

Correspodent Contact e.j. smith
Regulation Number 868.1840
Classification Product Code
BZG  
Date Received 12/06/2010
Decision Date 11/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No