The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Mortara Eli 10 Electrocardiograph.
| Device ID | K070539 |
| 510k Number | K070539 |
| Device Name: | MORTARA ELI 10 ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Contact | Laura M Spiegelhoff |
| Correspondent | Laura M Spiegelhoff MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-26 |
| Decision Date | 2007-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812345024821 | K070539 | 000 |
| 00812345024814 | K070539 | 000 |
| 00732094279610 | K070539 | 000 |
| 10812345023050 | K070539 | 000 |