The following data is part of a premarket notification filed by Mars Medical Products Co., Ltd. with the FDA for Vital Vision Arterial Hardness And Blood Pressure Monitor.
Device ID | K032825 |
510k Number | K032825 |
Device Name: | VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | MARS MEDICAL PRODUCTS CO., LTD. 1676 VILLAGE GREEN SUITE A Crofton, MD 21114 -4341 |
Contact | E.j. Smith |
Correspondent | E.j. Smith MARS MEDICAL PRODUCTS CO., LTD. 1676 VILLAGE GREEN SUITE A Crofton, MD 21114 -4341 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-10 |
Decision Date | 2004-12-10 |