K913927 is an FDA 510(k) clearance for the IL BG3 SYST, MODEL 1420, BLOOD GAS & PH TEST SYST. This device is classified as a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II - Special Controls, product code CHL).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on October 11, 1991, 38 days after receiving the submission on September 3, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1120.
| 510(k) Number | K913927 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 1991 |
| Decision Date | October 11, 1991 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CHL — Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1120 |