The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Eli 10 Electrocardiograph Model Eli 10.
| Device ID | K102206 |
| 510k Number | K102206 |
| Device Name: | ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 |
| 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 | 2010-08-05 |
| Decision Date | 2011-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812345024920 | K102206 | 000 |
| 00812345021783 | K102206 | 000 |