FDA 510(k) Application Details - K002079

Device Classification Name Automated External Defibrillators (Non-Wearable)

  More FDA Info for this Device
510(K) Number K002079
Device Name Automated External Defibrillators (Non-Wearable)
Applicant MEDICOTEST A/S
1900 K ST. N.W.
WASHINGTON, DC 20006-1108 US
Other 510(k) Applications for this Company
Contact EMALEE G MURPHY
Other 510(k) Applications for this Contact
Regulation Number 870.5310

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

  More FDA Info for this Product Code
Date Received 07/10/2000
Decision Date 02/22/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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