The following data is part of a premarket notification filed by Biomedical Life Systems, Inc. with the FDA for Electro Neuromuscular Stimulator, Model Nms-digital.
Device ID | K010749 |
510k Number | K010749 |
Device Name: | ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL |
Classification | Stimulator, Muscle, Powered |
Applicant | BIOMEDICAL LIFE SYSTEMS, INC. P.O. BOX 1360 Vista, CA 92085 -1360 |
Contact | Richard Saxon |
Correspondent | Richard Saxon BIOMEDICAL LIFE SYSTEMS, INC. P.O. BOX 1360 Vista, CA 92085 -1360 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-03-13 |
Decision Date | 2001-09-28 |