The following data is part of a premarket notification filed by Cns, Inc. with the FDA for Cns Satellite 100, 200, 1000, 2000 Electroence..
Device ID | K901549 |
510k Number | K901549 |
Device Name: | CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE. |
Classification | Full-montage Standard Electroencephalograph |
Applicant | CNS, INC. 7090 SHADY OAK RD. Eden Prairie, MN 55344 |
Contact | John F Stolte |
Correspondent | John F Stolte CNS, INC. 7090 SHADY OAK RD. Eden Prairie, MN 55344 |
Product Code | GWQ |
CFR Regulation Number | 882.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-03 |
Decision Date | 1990-10-24 |