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 |