The following data is part of a premarket notification filed by Emageon Inc. with the FDA for Heartsuite Hemodynamics 7.10.
| Device ID | K082421 |
| 510k Number | K082421 |
| Device Name: | HEARTSUITE HEMODYNAMICS 7.10 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | EMAGEON INC. 900 WALNUT RIDGE DRIVE Hartland, WI 53029 |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-08-22 |
| Decision Date | 2008-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842000100546 | K082421 | 000 |
| 00842000100188 | K082421 | 000 |
| 00842000100195 | K082421 | 000 |
| 00842000100201 | K082421 | 000 |
| 00842000100218 | K082421 | 000 |
| 00842000100249 | K082421 | 000 |
| 00842000100256 | K082421 | 000 |
| 00842000100263 | K082421 | 000 |
| 00842000100270 | K082421 | 000 |
| 00842000100515 | K082421 | 000 |
| 00842000100522 | K082421 | 000 |
| 00842000100539 | K082421 | 000 |
| 00842000100010 | K082421 | 000 |