The following data is part of a premarket notification filed by Medi-stim A/s with the FDA for Medi-stim Veriq System, Model Vq1001 - Vq4122.
Device ID | K040228 |
510k Number | K040228 |
Device Name: | MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122 |
Classification | Flowmeter, Blood, Cardiovascular |
Applicant | MEDI-STIM A/S 7601 NORTHLAND DRIVE MAILSTOP A150 Brooklyn Park, MN 55428 |
Contact | Jon H Hoem |
Correspondent | Jon H Hoem MEDI-STIM A/S 7601 NORTHLAND DRIVE MAILSTOP A150 Brooklyn Park, MN 55428 |
Product Code | DPW |
CFR Regulation Number | 870.2100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-02-02 |
Decision Date | 2004-04-29 |
Summary: | summary |