K820224 is an FDA 510(k) clearance for the EMIT FREELEVEL SYSTEM I. This device is classified as a Unit, Filter, Membrane (Class I - General Controls, product code JRL).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on February 23, 1982, 27 days after receiving the submission on January 27, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2050.
| 510(k) Number | K820224 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 1982 |
| Decision Date | February 23, 1982 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JRL — Unit, Filter, Membrane |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2050 |