K161295 is an FDA 510(k) clearance for the MiniBox +. This device is classified as a Calculator, Pulmonary Function Data (Class II - Special Controls, product code BZC).
Submitted by Pulmone Advanced Medical Devices, Ltd. (Ra?Ananna, IL). The FDA issued a Cleared decision on October 21, 2016, 165 days after receiving the submission on May 9, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1880.
| 510(k) Number | K161295 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2016 |
| Decision Date | October 21, 2016 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZC — Calculator, Pulmonary Function Data |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1880 |