510(k) K790664

MODEL 1309 AUDIO MONITOR by Life-Tech Instruments, Inc. — Product Code IKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1979
Date Received
April 6, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electromyograph, Diagnostic
Device Class
Class II
Regulation Number
890.1375
Review Panel
NE
Submission Type