The following data is part of a premarket notification filed by Mortara Instrument, Inc with the FDA for Eli 150 Electrocardiograph Model Eli 150.
Device ID | K101115 |
510k Number | K101115 |
Device Name: | ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 |
Classification | Electrocardiograph |
Applicant | MORTARA INSTRUMENT, INC 7865 NORTH 86TH STREET Milwaukee, WI 53224 |
Contact | Charles Morreale |
Correspondent | Charles Morreale MORTARA INSTRUMENT, INC 7865 NORTH 86TH STREET 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 | 2010-04-21 |
Decision Date | 2010-06-18 |
Summary: | summary |