The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Mortara Instrument Model El-1.
| Device ID | K851702 |
| 510k Number | K851702 |
| Device Name: | MORTARA INSTRUMENT MODEL EL-1 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MORTARA INSTRUMENT, INC. 8501 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Timothy C Mickelson |
| Correspondent | Timothy C Mickelson MORTARA INSTRUMENT, INC. 8501 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-24 |
| Decision Date | 1985-07-29 |