The following data is part of a premarket notification filed by Fysicon Bv with the FDA for Qmapp Amplifier; Qmapp Hemodynamic Monitoring System; Qmapp Pcm; Qmapp Go; Qmapp Ep.
| Device ID | K170032 |
| 510k Number | K170032 |
| Device Name: | QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Fysicon BV Hoogheuvelstraat 114 Oss, NL 5349 Ba |
| Contact | C.w.a (eric) Van Antwerpen |
| Correspondent | Patsy J. Trisler Qserve Group US Inc. 5600 Wisconsin Avenue Chevy Chase, MD 20815 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-04 |
| Decision Date | 2017-09-08 |
| Summary: | summary |