The following data is part of a premarket notification filed by I Needmd, Inc with the FDA for 12 Lead Glove.
| Device ID | K100315 |
| 510k Number | K100315 |
| Device Name: | 12 LEAD GLOVE |
| Classification | Electrode, Electrocardiograph |
| Applicant | I NEEDMD, INC 420 LEXINGTON AVENUE SUITE 2400 New York, NY 10170 |
| Contact | Irving L Wiesen, Esq |
| Correspondent | Irving L Wiesen, Esq I NEEDMD, INC 420 LEXINGTON AVENUE SUITE 2400 New York, NY 10170 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-04 |
| Decision Date | 2010-04-23 |