Seer Home
Full-montage Standard Electroencephalograph
Seer Medical Pty Ltd
The following data is part of a premarket notification filed by Seer Medical Pty Ltd with the FDA for Seer Home.
Pre-market Notification Details
| 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09355751001051 | K212788 | 000 |
| 09355751001044 | K212788 | 000 |
| 09355751001020 | K212788 | 000 |
| 09355751001136 | K212788 | 000 |
| 09355751001037 | K212788 | 000 |
Trademark Results [Seer Home]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SEER HOME 79340655 not registered Live/Pending |
Seer Medical Pty Ltd 2022-03-11 |
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