The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Eli Pc Electrocardiograph.
| Device ID | K093339 |
| 510k Number | K093339 |
| Device Name: | ELI PC 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 | 2009-10-26 |
| Decision Date | 2010-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817655020044 | K093339 | 000 |
| 00732094271799 | K093339 | 000 |
| 00732094271775 | K093339 | 000 |
| 00732094271751 | K093339 | 000 |
| 00732094336016 | K093339 | 000 |
| 00732094296631 | K093339 | 000 |
| 00732094261424 | K093339 | 000 |
| 00732094261417 | K093339 | 000 |
| 00732094261356 | K093339 | 000 |
| 00732094261288 | K093339 | 000 |
| 00732094261271 | K093339 | 000 |
| 00732094349658 | K093339 | 000 |
| 00732094261349 | K093339 | 000 |
| 00732094271836 | K093339 | 000 |
| 00732094272086 | K093339 | 000 |
| 00732094272093 | K093339 | 000 |
| 00732094318029 | K093339 | 000 |
| 00732094318012 | K093339 | 000 |
| 00732094271744 | K093339 | 000 |
| 00732094272253 | K093339 | 000 |
| 00732094272130 | K093339 | 000 |
| 00732094272123 | K093339 | 000 |
| 00732094272116 | K093339 | 000 |
| 00732094271898 | K093339 | 000 |
| 00732094271812 | K093339 | 000 |
| 00732094326680 | K093339 | 000 |
| 00732094328950 | K093339 | 000 |
| 00732094272109 | K093339 | 000 |
| 00817655020884 | K093339 | 000 |