510(k) K862236

MYOLAB II, MODEL ML-200 by Motion Control, Inc. — Product Code IKN

K862236 is an FDA 510(k) premarket notification submitted by Motion Control, Inc. for the device "MYOLAB II, MODEL ML-200". The FDA issued a decision of Substantially Equivalent on August 7, 1986. The device falls under product code IKN (Electromyograph, Diagnostic), a Class II device regulated under 21 CFR 890.1375. Motion Control, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1986
Date Received
June 11, 1986
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