K160116 is an FDA 510(k) clearance for the SpiroScout. This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Ganshorn Medizin Electronic GmbH (Niederlauer, DE). The FDA issued a Cleared decision on October 7, 2016, 262 days after receiving the submission on January 19, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K160116 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 2016 |
| Decision Date | October 07, 2016 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZG - Spirometer, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1840 |