The following data is part of a premarket notification filed by Thought Technology Ltd. with the FDA for M(3):micro Muscle Monitor.
Device ID | K896409 |
510k Number | K896409 |
Device Name: | M(3):MICRO MUSCLE MONITOR |
Classification | Device, Biofeedback |
Applicant | THOUGHT TECHNOLOGY LTD. 2180 BELGRAVE AVE. Montreal, Quebec, CA H4a 2l8 |
Contact | Hal K Myers |
Correspondent | Hal K Myers THOUGHT TECHNOLOGY LTD. 2180 BELGRAVE AVE. Montreal, Quebec, CA H4a 2l8 |
Product Code | HCC |
CFR Regulation Number | 882.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-07 |
Decision Date | 1990-10-09 |