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 |