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 |