510(k) K010749

ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL by Biomedical Life Systems, Inc. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2001
Date Received
March 13, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type