K062155 is an FDA 510(k) clearance for the DIGITAL MXR-D FLOWMETER. This device is classified as a Gas-machine, Anesthesia (Class II - Special Controls, product code BSZ).
Submitted by Porter Instrument Co., Inc. (North Attleboro, US). The FDA issued a Cleared decision on November 9, 2006, 104 days after receiving the submission on July 28, 2006.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5160.
| 510(k) Number | K062155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2006 |
| Decision Date | November 09, 2006 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BSZ — Gas-machine, Anesthesia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5160 |