The following data is part of a premarket notification filed by Dynacardia, Inc. with the FDA for Quantitative Electrocardiographic Detector (qed 1000).
| Device ID | K093172 |
| 510k Number | K093172 |
| Device Name: | QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000) |
| Classification | Electrocardiograph |
| Applicant | DYNACARDIA, INC. 1330 MOUNTAIN VIEW CIR. Azusa, CA 91702 |
| Correspondent | Morten S Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-10-08 |
| Decision Date | 2010-01-20 |
| Summary: | summary |