Identifiers
- 510(k) Number
- K190853 FDA 510(k)
- FDA Product Code
- BZC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1880 FDA 510(k)
- Regulation Number
- 868.1880 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vyntus BODY is a pulmonary function data calculator and body plethysmograph used for measuring lung volumes and airway resistance. It features Resistance Volume Loops as a unique graphical aid to display the relationship between airway resistance and lung volumes, and incorporates ultrasonic sensor Double Shot Technology for enhanced data resolution and precision.
The device includes a flexible arm that can be extended outside the cabin up to 24.8 inches, is adjustable in height and position, and accommodates patients in wheelchairs for comfortable measurement. It is supplied as a reusable system requiring the addition of Vyntus TM ONE for operation, and is classified as a Class II medical device under FDA 510(k) clearance K190853 with product code BZC.
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: PDF VyntusTM BODY - care.vyaire.com, Vyntus™ BODY Plethysmograph - jaegerrdx.com, PDF Vyntus BODY
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190853 | Class II | Active |
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Manufacturer
- Manufacturer
- Vyaire Medical, Inc.
Sources (1)
- FDA 510(k) K190853 24 fields · synced Oct 6, 2026