The following data is part of a premarket notification filed by Neuroinvent Inc. with the FDA for E-shield Multi-paired Subdermal Needle Electrodes.
| Device ID | K140200 |
| 510k Number | K140200 |
| Device Name: | E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES |
| Classification | Electrode, Needle |
| Applicant | NEUROINVENT INC. 5F,NO.123,ANMEI ST.,NEIHU DISTRICT, Taipei City, TW 11484 |
| Contact | Chao-shent Chao |
| Correspondent | Chao-shent Chao NEUROINVENT INC. 5F,NO.123,ANMEI ST.,NEIHU DISTRICT, Taipei City, TW 11484 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-27 |
| Decision Date | 2014-07-18 |
| Summary: | summary |