The following data is part of a premarket notification filed by Thought Technology Ltd. with the FDA for Emg 100t.
Device ID | K822814 |
510k Number | K822814 |
Device Name: | EMG 100T |
Classification | Device, Biofeedback |
Applicant | THOUGHT TECHNOLOGY LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HCC |
CFR Regulation Number | 882.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-09-20 |
Decision Date | 1982-10-08 |