FDA 510(k) Application Details - K021605

Device Classification Name Computer, Oxygen-Uptake

  More FDA Info for this Device
510(K) Number K021605
Device Name Computer, Oxygen-Uptake
Applicant HEALTHETECH, INC.
523 PARK POINT DR.
GOLDEN, CO 80401 US
Other 510(k) Applications for this Company
Contact GLENN M THIBAULT
Other 510(k) Applications for this Contact
Regulation Number 868.1730

  More FDA Info for this Regulation Number
Classification Product Code BZL
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 05/16/2002
Decision Date 06/14/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact