The following data is part of a premarket notification filed by Utah Medical Products, Inc. with the FDA for Neuromuscular Transmission Monitor.
Device ID | K905092 |
510k Number | K905092 |
Device Name: | NEUROMUSCULAR TRANSMISSION MONITOR |
Classification | Stimulator, Nerve, Battery-powered |
Applicant | UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
Contact | Edwin O Goodman |
Correspondent | Edwin O Goodman UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST Midvale, UT 84047 -1048 |
Product Code | BXN |
CFR Regulation Number | 868.2775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-14 |
Decision Date | 1991-06-25 |