The following data is part of a premarket notification filed by Suzhou Ennova Electronics Technology Co.,ltd with the FDA for Ennova Self-adhesive Electrode.
| Device ID | K152648 |
| 510k Number | K152648 |
| Device Name: | Ennova Self-adhesive Electrode |
| Classification | Electrode, Cutaneous |
| Applicant | Suzhou Ennova Electronics Technology Co.,Ltd Jinsigang Industrial Park, Guoxiang, Wuzhong District, Suzhou, CN 215124 |
| Contact | N/a N/a |
| Correspondent | Doris Dong SHANGHAI CV TECHNOLOGY CO., LTD ROOM 1706, NO.128 SONGLE RD., SONGJIANG AREA Shanghai, CN 201600 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-16 |
| Decision Date | 2016-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16973265920080 | K152648 | 000 |