FDA 510(k) Application Details - K010187

Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified

  More FDA Info for this Device
510(K) Number K010187
Device Name System, X-Ray, Fluoroscopic, Image-Intensified
Applicant MEDICAL METRICS, INC.
4600 NORTH PARK AVE.
SUITE 100
CHEVY CHASE, MD 20815-4518 US
Other 510(k) Applications for this Company
Contact ANN TUNSTALL
Other 510(k) Applications for this Contact
Regulation Number 892.1650

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

  More FDA Info for this Product Code
Date Received 01/22/2001
Decision Date 02/14/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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