The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Mingograf Eeg10.
Device ID | K802296 |
510k Number | K802296 |
Device Name: | MINGOGRAF EEG10 |
Classification | Full-montage Standard Electroencephalograph |
Applicant | SIEMENS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GWQ |
CFR Regulation Number | 882.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-19 |
Decision Date | 1980-10-03 |