K200594 is an FDA 510(k) clearance for the Capnostream 35 Portable Respiratory Monitor. This device is classified as a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II - Special Controls, product code CCK).
Submitted by Oridion Medical 1987 , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on April 27, 2020, 52 days after receiving the submission on March 6, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1400.
| 510(k) Number | K200594 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2020 |
| Decision Date | April 27, 2020 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CCK - Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1400 |