The following data is part of a premarket notification filed by Neuroinvent Inc. with the FDA for E-shield Multi-paried Subdermal Needle Electrodes.
| Device ID | K142470 |
| 510k Number | K142470 |
| Device Name: | E-Shield Multi-paried Subdermal Needle Electrodes |
| Classification | Electrode, Needle |
| Applicant | NEUROINVENT INC. 19925 STEVENS CREEK BLVD., STE 100 Cupertino, CA 95014 |
| Contact | Chao Shent-chao |
| Correspondent | Chao Shent-chao NEUROINVENT INC. 19925 STEVENS CREEK BLVD., STE 100 Cupertino, CA 95014 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-03 |
| Decision Date | 2014-11-05 |
| Summary: | summary |