The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Mortara Monitoring Waveform Viewer.
| Device ID | K141811 |
| 510k Number | K141811 |
| Device Name: | MORTARA MONITORING WAVEFORM VIEWER |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| 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 | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-07 |
| Decision Date | 2014-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812345029819 | K141811 | 000 |
| 00732094296341 | K141811 | 000 |