Spiro Analyzer St-300
by Futuremed Div. of Future Impex Corp. 510(k)
Active
510(k) K873817
Overview
The SPIRO ANALYZER ST-300 is a diagnostic spirometer used for pulmonary function testing. It measures and analyzes respiratory parameters to assess lung capacity and airflow. The device is classified under product code BZG as a Class II medical device with special controls.
This device was cleared through the FDA 510(k) premarket notification pathway under k-number K873817, with a decision date of December 2, 1987. It is manufactured by Futuremed Div. of Future Impex Corp., located in Deerpark, US. The submission was reviewed by the Anesthesiology advisory committee and determined to be substantially equivalent to existing devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK873817 | Date2 Dec 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Futuremed Div. of Future Impex Corp.
Questions
What is the SPIRO ANALYZER ST-300 used for?
The SPIRO ANALYZER ST-300 is a diagnostic spirometer used for pulmonary function testing. It measures and analyzes respiratory parameters to assess lung capacity and airflow, helping clinicians evaluate a patient's respiratory function.
How is the SPIRO ANALYZER ST-300 supplied?
The device is supplied by Futuremed Div. of Future Impex Corp., located at 2076 Deer Park Ave., Deerpark, NY 11729, US. Specific packaging or distribution details are not provided in the available data, so direct inquiry with the manufacturer or authorized supplier is recommended for procurement information.
Is the SPIRO ANALYZER ST-300 sterile?
The available device data does not specify whether the SPIRO ANALYZER ST-300 is supplied sterile or non-sterile. For clinical use requiring sterility, confirmation with the manufacturer or supplier regarding the device's sterilization status and packaging is necessary before deployment.
Is the SPIRO ANALYZER ST-300 single-use or reusable?
The device data does not explicitly state whether the SPIRO ANALYZER ST-300 is designed for single-use or multiple patient reuse. As a diagnostic spirometer used in pulmonary function testing, it may involve reusable components or disposable mouthpieces; users should consult the manufacturer's instructions for use to determine the intended reprocessing and reuse protocol.
What is the regulatory route for the SPIRO ANALYZER ST-300?
The SPIRO ANALYZER ST-300 was cleared through the FDA 510(k) premarket notification pathway under k-number K873817, with a decision date of December 2, 1987. It is classified under product code BZG as a Class II medical device with special controls, and the submission was reviewed by the Anesthesiology advisory committee, resulting in a determination of substantial equivalence.