The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Mortara Instrument Model Eli 50.
| Device ID | K902652 |
| 510k Number | K902652 |
| Device Name: | MORTARA INSTRUMENT MODEL ELI 50 |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Contact | Lawrence A Niemi |
| Correspondent | Lawrence A Niemi MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-15 |
| Decision Date | 1990-08-23 |