The following data is part of a premarket notification filed by Philips Consumer Lifestyle with the FDA for Philips Self-adhesive Electrodes.
Device ID | K151033 |
510k Number | K151033 |
Device Name: | Philips Self-Adhesive Electrodes |
Classification | Electrode, Cutaneous |
Applicant | PHILIPS CONSUMER LIFESTYLE 1600 SUMMER STREET Stamford, CT 06905 |
Contact | Marta Walker |
Correspondent | Marta Walker PHILIPS CONSUMER LIFESTYLE 1600 SUMMER STREET Stamford, CT 06905 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-04-17 |
Decision Date | 2015-07-28 |
Summary: | summary |