K161718 is an FDA 510(k) clearance for the MaxBlend 2, MaxBlend Lite. This device is classified as a Mixer, Breathing Gases, Anesthesia Inhalation (Class II - Special Controls, product code BZR).
Submitted by Maxtec, LLC (Salt Lake City, US). The FDA issued a Cleared decision on October 27, 2016, 127 days after receiving the submission on June 22, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5330.
| 510(k) Number | K161718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2016 |
| Decision Date | October 27, 2016 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZR - Mixer, Breathing Gases, Anesthesia Inhalation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5330 |