The following data is part of a premarket notification filed by Seer Medical Pty Ltd with the FDA for Seer Home.
Device ID | K212788 |
510k Number | K212788 |
Device Name: | Seer Home |
Classification | Full-montage Standard Electroencephalograph |
Applicant | Seer Medical Pty Ltd Melbourne, AU 3133 |
Contact | David Mitchell |
Correspondent | David Mitchell Seer Medical Pty Ltd Melbourne, AU 3133 |
Product Code | GWQ |
CFR Regulation Number | 882.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-09-01 |
Decision Date | 2022-06-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
09355751001051 | K212788 | 000 |
09355751001181 | K212788 | 000 |
09355751001228 | K212788 | 000 |
09355751001235 | K212788 | 000 |
09355751001242 | K212788 | 000 |
09355751001037 | K212788 | 000 |
09355751001136 | K212788 | 000 |
09355751001020 | K212788 | 000 |
09355751001044 | K212788 | 000 |
09355751001174 | K212788 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SEER HOME 79340655 not registered Live/Pending |
Seer Medical Pty Ltd 2022-03-11 |