The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Mortara Eli 350 Electrocardiograph.
| Device ID | K082946 |
| 510k Number | K082946 |
| Device Name: | MORTARA ELI 350 ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Contact | Charles Morreale |
| Correspondent | Charles Morreale MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-02 |
| Decision Date | 2008-12-29 |
| Summary: | summary |