MEDDORNA WIRELESS PRN SPIROMETER 100


Device Classification Name

spirometer, diagnostic

510(k) Number K072722
Device Name MEDDORNA WIRELESS PRN SPIROMETER 100
Applicant
MEDDORNA LLC
11874 south evelyn circle
houston, 
TX 
77071

Applicant Contact j. harvey knauss
Regulation Number 868.1840
Classification Product Code
BZG  
Date Received 09/26/2007
Decision Date 04/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No