K240293 is an FDA 510(k) clearance for the STS. This device is classified as a Calculator, Pulmonary Function Data (Class II - Special Controls, product code BZC).
Submitted by Techbopulm, Ltd. (Yad Benyamin, IL). The FDA issued a Cleared decision on September 17, 2024, 229 days after receiving the submission on February 1, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1880.
| 510(k) Number | K240293 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2024 |
| Decision Date | September 17, 2024 |
| Days to Decision | 229 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 |