GEM, MODEL 004110


Device Classification Name

spirometer, diagnostic

510(k) Number K030464
Device Name GEM, MODEL 004110
Applicant
COLLINS MEDICAL, INC.
220 wood rd.
braintree, 
MA 
02184 -2408

Applicant Contact donald henton
Correspondent
COLLINS MEDICAL, INC.
220 wood rd.
braintree, 
MA 
02184 -2408

Correspodent Contact donald henton
Regulation Number 868.1840
Classification Product Code
BZG  
Date Received 02/12/2003
Decision Date 03/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No