MEDGEM


Device Classification Name

computer, oxygen-uptake

510(k) Number K021605
Device Name MEDGEM
Original Applicant
HEALTHETECH, INC.
523 park point dr.
golden, 
CO 
80401

Original Contact glenn m thibault
Regulation Number 868.1730
Classification Product Code
BZL  
Date Received 05/16/2002
Decision Date 06/14/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No