K863420 is an FDA 510(k) clearance for the VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR. This device is classified as a Analyzer, Gas, Carbon-monoxide, Gaseous-phase (Class II - Special Controls, product code CCJ).
Submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on January 15, 1987, 133 days after receiving the submission on September 4, 1986.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1430.
| 510(k) Number | K863420 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 1986 |
| Decision Date | January 15, 1987 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | - |
| Product Code | CCJ - Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1430 |