FDA 510(k) Application Details - K041694

Device Classification Name Thermometer, Electronic, Clinical

  More FDA Info for this Device
510(K) Number K041694
Device Name Thermometer, Electronic, Clinical
Applicant HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
BUILDING 2, BAIMIAO INDU. PARK
ECONOMIC DEVELOP. ZONE WUCHANG
HANGZHOU, ZHEJIANG 310023 CN
Other 510(k) Applications for this Company
Contact JI BO
Other 510(k) Applications for this Contact
Regulation Number 880.2910

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

  More FDA Info for this Product Code
Date Received 06/22/2004
Decision Date 09/13/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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