510(k) K042484

NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER by Nai Technology Products — Product Code LMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2004
Date Received
September 13, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Digitizer, Image, Radiological
Device Class
Class II
Regulation Number
892.2030
Review Panel
RA
Submission Type