The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Eli 350 Electrocardiograph.
| Device ID | K092663 |
| 510k Number | K092663 |
| Device Name: | 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-31 |
| Decision Date | 2009-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812345025347 | K092663 | 000 |
| 00812345021912 | K092663 | 000 |
| 00812345021905 | K092663 | 000 |
| 00812345021899 | K092663 | 000 |
| 00812345021882 | K092663 | 000 |
| 00812345021875 | K092663 | 000 |
| 00812345021868 | K092663 | 000 |
| 00812345021851 | K092663 | 000 |
| 00812345021844 | K092663 | 000 |
| 00812345021837 | K092663 | 000 |
| 00812345021820 | K092663 | 000 |
| 00812345021813 | K092663 | 000 |
| 00812345021806 | K092663 | 000 |
| 00812345021929 | K092663 | 000 |
| 00812345021936 | K092663 | 000 |
| 00812345021943 | K092663 | 000 |
| 00812345025323 | K092663 | 000 |
| 00812345025309 | K092663 | 000 |
| 00812345025286 | K092663 | 000 |
| 00812345025262 | K092663 | 000 |
| 00812345025248 | K092663 | 000 |
| 00812345025224 | K092663 | 000 |
| 00812345025200 | K092663 | 000 |
| 00812345025187 | K092663 | 000 |
| 00812345025163 | K092663 | 000 |
| 00812345025149 | K092663 | 000 |
| 00812345025125 | K092663 | 000 |
| 00812345025101 | K092663 | 000 |
| 00732094294088 | K092663 | 000 |