K241843 is an FDA 510(k) clearance for the TD-7301 Spirometer (TD-7301). This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Gostar Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on November 20, 2024, 147 days after receiving the submission on June 26, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K241843 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2024 |
| Decision Date | November 20, 2024 |
| Days to Decision | 147 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 |