The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Flush Solution Concentrate-blood Gas.
| Device ID | K840300 |
| 510k Number | K840300 |
| Device Name: | FLUSH SOLUTION CONCENTRATE-BLOOD GAS |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | BIONOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-24 |
| Decision Date | 1984-03-23 |