The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Quik - Prep2 Electrode.
| Device ID | K821757 |
| 510k Number | K821757 |
| Device Name: | QUIK - PREP2 ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | QUINTON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-15 |
| Decision Date | 1982-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 21081234502474 | K821757 | 000 |