The following data is part of a premarket notification filed by Cardiac Lead Technologies, Inc. with the FDA for Qwiklead Reusable Electrocardiograph Electrode Patch.
| Device ID | K090496 |
| 510k Number | K090496 |
| Device Name: | QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH |
| Classification | Electrode, Electrocardiograph |
| Applicant | CARDIAC LEAD TECHNOLOGIES, INC. 575 7TH ST. NW Washinton, DC 20004 |
| Contact | Claudia Lewis-eng |
| Correspondent | Claudia Lewis-eng CARDIAC LEAD TECHNOLOGIES, INC. 575 7TH ST. NW Washinton, DC 20004 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-25 |
| Decision Date | 2009-09-01 |
| Summary: | summary |