The following data is part of a premarket notification filed by Bio Medicus, Inc. with the FDA for Bio-probe System-blood Flow Probe.
Device ID | K830858 |
510k Number | K830858 |
Device Name: | BIO-PROBE SYSTEM-BLOOD FLOW PROBE |
Classification | Probe, Blood-flow, Extravascular |
Applicant | BIO MEDICUS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DPT |
CFR Regulation Number | 870.2120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-17 |
Decision Date | 1983-06-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10681490408667 | K830858 | 000 |
20673978563330 | K830858 | 000 |
20721902987780 | K830858 | 000 |
20885074495747 | K830858 | 000 |