The following data is part of a premarket notification filed by Vsm Technology, Inc. with the FDA for Modification To Automated Non-invasive Blood Pressure Monitor, Model Bpm-100.
Device ID | K002046 |
510k Number | K002046 |
Device Name: | MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | VSM TECHNOLOGY, INC. 555 13TH ST. NW Washington, DC 20004 -1109 |
Contact | Howard M Holstein |
Correspondent | Howard M Holstein VSM TECHNOLOGY, INC. 555 13TH ST. NW Washington, DC 20004 -1109 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-07-05 |
Decision Date | 2000-07-21 |