The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Eli 200+ Audicor.
| Device ID | K031182 |
| 510k Number | K031182 |
| Device Name: | ELI 200+ AUDICOR |
| Classification | Electrocardiograph |
| Applicant | MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
| Contact | Harlan L Van Matre |
| Correspondent | Chantel Carson UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-04-15 |
| Decision Date | 2003-07-25 |
| Summary: | summary |