FDA 510(k) Application Details - K023613

Device Classification Name Processor, Radiographic-Film, Automatic

  More FDA Info for this Device
510(K) Number K023613
Device Name Processor, Radiographic-Film, Automatic
Applicant ALPHATEK CORP.
2000 SOUTH 25TH AVE.
BROADVIEW, IL 60153 US
Other 510(k) Applications for this Company
Contact PAUL M KUPSCO
Other 510(k) Applications for this Contact
Regulation Number 892.1900

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

  More FDA Info for this Product Code
Date Received 10/28/2002
Decision Date 01/23/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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