The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Eli 280 Electrocardiograph.
Device ID | K122073 |
510k Number | K122073 |
Device Name: | ELI 280 ELECTROCARDIOGRAPH |
Classification | Electrocardiograph |
Applicant | MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. Milwaukee, WI 53224 |
Contact | Amy Yang |
Correspondent | Amy Yang 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 | 2012-07-16 |
Decision Date | 2012-08-02 |
Summary: | summary |