The following data is part of a premarket notification filed by Athena Gtx with the FDA for Athena Gtx Device Management Suite (adms) Software.
| Device ID | K173203 |
| 510k Number | K173203 |
| Device Name: | Athena GTX Device Management Suite (ADMS) Software |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | Athena GTX 5900 NW 86th Street, Suite 300 Johnston, IA 50131 |
| Contact | Sean Mahoney |
| Correspondent | Sean Mahoney Athena GTX 5900 NW 86th Street, Suite 300 Johnston, IA 50131 |
| Product Code | MSX |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRG |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DXN |
| Subsequent Product Code | MHX |
| Subsequent Product Code | MLD |
| Subsequent Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-02 |
| Decision Date | 2018-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3943950010000 | K173203 | 000 |
| B3943950009000 | K173203 | 000 |
| B3943900008000 | K173203 | 000 |