The following data is part of a premarket notification filed by Neurocom International, Inc. with the FDA for Emg Accessory For Posturography.
Device ID | K901732 |
510k Number | K901732 |
Device Name: | EMG ACCESSORY FOR POSTUROGRAPHY |
Classification | Electromyograph, Diagnostic |
Applicant | NEUROCOM INTERNATIONAL, INC. 9570 S.E. LAWNFIELD RD. Clackamas, OR 97015 |
Contact | Jack Fassel |
Correspondent | Jack Fassel NEUROCOM INTERNATIONAL, INC. 9570 S.E. LAWNFIELD RD. Clackamas, OR 97015 |
Product Code | IKN |
CFR Regulation Number | 890.1375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-17 |
Decision Date | 1991-09-10 |