BODYGEM, MODEL HB211


Device Classification Name

computer, oxygen-uptake

510(k) Number K010577
Device Name BODYGEM, MODEL HB211
Original Applicant
HEALTHETECH, INC.
325 los gatos-saratoga rd.
los gatos, 
CA 
95070

Original Contact noel l johnson
Regulation Number 868.1730
Classification Product Code
BZL  
Date Received 02/27/2001
Decision Date 01/10/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No