The following data is part of a premarket notification filed by Mdoloris Medical Systems Sas with the FDA for Ani Monitor.
| Device ID | K142969 |
| 510k Number | K142969 |
| Device Name: | ANI Monitor |
| Classification | Electrocardiograph |
| Applicant | MDOLORIS MEDICAL SYSTEMS SAS 6, RUE DU PR LAGUESSE Lille, FR 59037 |
| Contact | Mathilde Collet |
| Correspondent | Thomas Kroenke SPEED TO MARKET, INC. PO BOX 3018 Nederland, CO 80466 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-14 |
| Decision Date | 2016-02-23 |
| Summary: | summary |