K862253 is an FDA 510(k) clearance for the IL 482 CO-OXIMETER. This device is classified as a Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide (Class I - General Controls, product code JKS).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on July 29, 1986, 46 days after receiving the submission on June 13, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3220.
| 510(k) Number | K862253 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 1986 |
| Decision Date | July 29, 1986 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JKS — Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3220 |