Pure EP
Computer, Diagnostic, Programmable
BioSig Technologies
The following data is part of a premarket notification filed by Biosig Technologies with the FDA for Pure Ep.
Pre-market Notification Details
| Device ID | K180805 |
| 510k Number | K180805 |
| Device Name: | Pure EP |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | BioSig Technologies 12424 Wilshire Blvd, Suite 745 Los Angeles, CA 90025 |
| Contact | Tiffini Wittwer |
| Correspondent | Tiffini Wittwer BioSig Technologies 12424 Wilshire Blvd, Suite 745 Los Angeles, CA 90025 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-28 |
| Decision Date | 2018-08-08 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08567500070008 | K180805 | 000 |
| 00856750007109 | K180805 | 000 |
| 00856750007116 | K180805 | 000 |
| 00856750007130 | K180805 | 000 |
| 00856750007147 | K180805 | 000 |
| 00856750007154 | K180805 | 000 |
| 00856750007161 | K180805 | 000 |
| 00856750007178 | K180805 | 000 |
| 00856750007031 | K180805 | 000 |
| 00856750007048 | K180805 | 000 |
| 00856750007055 | K180805 | 000 |
| 00856750007123 | K180805 | 000 |
| 00856750007000 | K180805 | 000 |
| 00856750007093 | K180805 | 000 |
Trademark Results [Pure EP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PURE EP 85617649 4893253 Live/Registered |
BIOSIG TECHNOLOGIES, INC. 2012-05-04 |
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