The following data is part of a premarket notification filed by Datrix with the FDA for Cardioserver.
| Device ID | K052883 |
| 510k Number | K052883 |
| Device Name: | CARDIOSERVER |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | DATRIX 340 STATE PLACE Escondido, CA 92029 |
| Contact | Linda Gluckman |
| 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 | 2005-10-13 |
| Decision Date | 2005-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860991000324 | K052883 | 000 |
| 00860991000317 | K052883 | 000 |
| 00860991000300 | K052883 | 000 |
| 00860991000348 | K052883 | 000 |
| 00860991000355 | K052883 | 000 |
| 00860991000362 | K052883 | 000 |
| 00860991000379 | K052883 | 000 |
| 00860991000386 | K052883 | 000 |
| 00860991000393 | K052883 | 000 |