The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Mortara Instrument Model Eli-xr (treadmill Included).
| Device ID | K880664 |
| 510k Number | K880664 |
| Device Name: | MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED) |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Contact | Timothy Mickelson |
| Correspondent | Timothy Mickelson MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-18 |
| Decision Date | 1988-03-09 |