The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Xscribe Stress Exercise Testing Systems, Q-stress Stress Exercise Testing Systems.
| Device ID | K152944 |
| 510k Number | K152944 |
| Device Name: | Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems |
| Classification | Electrocardiograph |
| Applicant | MORTARA INSTRUMENT, INC. 7865 NORTH 86TH STREET Milwaukee, WI 53224 |
| Contact | Eleanore Dias |
| Correspondent | Eleanore Dias MORTARA INSTRUMENT, INC. 7865 NORTH 86TH STREET Milwaukee, WI 53224 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-06 |
| Decision Date | 2016-01-06 |
| Summary: | summary |