SPIROVISION SV-III PC Based Spirometer Kit Micro
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K953948 FDA 510(k)
- FDA Product Code
- BZG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1840 FDA 510(k)
- Regulation Number
- 868.1840 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SPIROVISION SV-III PC Based Spirometer Kit Micro is a diagnostic spirometer designed to convert a personal computer into a functional spirometry system. It is used for performing pulmonary function tests including FVC, SVC, and MVV measurements, and supports flow-volume loops, time/volume curves, pre/post comparisons, and broncho-challenge testing. The device is intended for use in occupational, primary care, and pulmonary clinical settings.
This single-use system is supplied as a kit and is intended for use with a patient’s choice of mouthpiece or bacterial filter. It is a Class II medical device with FDA 510(k) clearance under number K953948, determined substantially equivalent. The device is manufactured by Futuremed America, Inc., located in Chatsworth, California, and is not described as MRI safe in the provided data. Storage conditions and additional regulatory details are not specified in the available records.
Frequently asked questions
What pulmonary function tests can the SpiroVision SV-III perform?
The kit supports forced vital capacity (FVC), slow vital capacity (SVC), maximum voluntary ventilation (MVV), flow‑volume loops, time/volume curves, pre‑ and post‑test comparisons, and broncho‑challenge testing, providing a comprehensive set of measurements for clinical assessment.
How is the device supplied and what components are included?
It is delivered as a single‑use kit that contains the PC‑based hardware and software needed to perform spirometry. Clinicians must provide a patient‑selected mouthpiece or bacterial filter, allowing flexibility while keeping the core system sterile and ready for immediate use.
Is the SpiroVision SV-III intended for single‑use or can it be reused?
The system is marketed as a single‑use kit. While the PC interface can be reused, the disposable components—including the sensor assembly—are intended for one patient only to maintain hygiene and measurement accuracy.
What regulatory classification does this spirometer have?
The SpiroVision SV-III is classified as a Class II medical device and has received FDA 510(k) clearance (K953948) as substantially equivalent to a predicate device, confirming it meets the necessary safety and performance standards for diagnostic use.
Where should the kit be stored before use?
The available data do not specify storage conditions, so manufacturers typically advise keeping the kit in a clean, dry environment at room temperature, protected from extreme temperatures and moisture to preserve component integrity.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SpiroVision-3+ - FUTUREMED, SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO (K953948) — FDA 510 (k ..., NEW SpiroVision-3+ Spirometer - futuremedamerica.com, PDF SpiroVision 3 - futuremed.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K953948 | Class II | Active |
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Manufacturer
- Manufacturer
- Futuremed America, Inc.
Sources (1)
- FDA 510(k) K953948 24 fields · synced Sep 22, 2026