The following data is part of a premarket notification filed by Fms, Finapres Medical Systems Bv with the FDA for Finometer Noninvasive Hemodynamic Monitor, Model 1.
Device ID | K023723 |
510k Number | K023723 |
Device Name: | FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1 |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | FMS, FINAPRES MEDICAL SYSTEMS BV 1205 DE LA VINA ST. Santa Barbara, CA 93101 |
Contact | Christine Emanuel |
Correspondent | Christine Emanuel FMS, FINAPRES MEDICAL SYSTEMS BV 1205 DE LA VINA ST. Santa Barbara, CA 93101 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-05 |
Decision Date | 2003-10-23 |
Summary: | summary |