K951366 is an FDA 510(k) clearance for the RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18). This device is classified as a Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) (Class II - Special Controls, product code CBS).
Submitted by Riken Keiki Co., Ltd. (Wales Center, US). The FDA issued a Cleared decision on August 2, 1995, 128 days after receiving the submission on March 27, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1620.
| 510(k) Number | K951366 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1995 |
| Decision Date | August 02, 1995 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CBS — Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1620 |