TD-7301 Spirometer (TD-7301)
510(k) K241843
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241843 | Date20 Nov 2024 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BZG
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1840
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs. The TD-7301 Spirometer (TD-7301) is a Class II medical device with product code BZG and regulation number 868.1840.
It is manufactured by Gostar Co., Ltd. and received FDA 510(k) clearance (K241843) on November 20, 2024. The device is intended for use in anesthesiology and pulmonary function testing environments.
Other devices from Gostar Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the TD-7301 Spirometer used for?
The TD-7301 Spirometer is used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs, specifically intended for use in anesthesiology and pulmonary function testing environments.
Who manufactures the TD-7301 Spirometer and when was it cleared?
The TD-7301 Spirometer is manufactured by Gostar Co., Ltd. and received FDA 510(k) clearance (K241843) on November 20, 2024, following submission on June 26, 2024.
What regulatory classification and product code does the TD-7301 Spirometer have?
The TD-7301 Spirometer is a Class II medical device with product code BZG and regulation number 868.1840, as determined by its FDA 510(k) clearance process.