K112173 is an FDA 510(k) clearance for the SPEACELABS MULTIGAS MODULE. This device is classified as a Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.) (Class II - Special Controls, product code CBR).
Submitted by Spacelabs Healthcare (Nederland, US). The FDA issued a Cleared decision on October 5, 2011, 69 days after receiving the submission on July 28, 2011.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1700.
| 510(k) Number | K112173 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2011 |
| Decision Date | October 05, 2011 |
| Days to Decision | 69 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBR — Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1700 |