Identifiers
- 510(k) Number
- K920332 FDA 510(k)
- FDA Product Code
- CAF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5630 FDA 510(k)
- Regulation Number
- 868.5630 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. This device is classified as a Nebulizer (direct Patient Interface) under product code CAF.
It was cleared by the FDA through the 510(k) process under K920332 on May 26, 1992, following a traditional review. The device is manufactured by Vortran Medical Technology 1, Inc. in Sacramento, California.
Frequently asked questions
What is the HEART NUBULIZER intended for?
The HEART NUBULIZER is intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing, as a nebulizer with direct patient interface under product code CAF.
How was the HEART NUBULIZER cleared for market?
The HEART NUBULIZER was cleared by the FDA through the 510(k) process under K920332 on May 26, 1992, following a traditional review and was found substantially equivalent to a predicate device.
Who manufactures the HEART NUBULIZER and where is it made?
The HEART NUBULIZER is manufactured by Vortran Medical Technology 1, Inc. at their facility located at 3941 J St., Suite 354, Sacramento, California, 95819, United States.
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: VORTRAN | United States | VORTRAN Medical, K920332 FDA 510 (k) - HEART NUBULIZER, HEART NEBULIZER #100609 by VORTRAN MEDICAL TECHNOLOGY 1, INC. | FDA 510 ..., K963910 FDA 510 (k) - HEART NEBULIZER #100609
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K920332 | Class II | Active |
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Manufacturer
- Manufacturer
- Vortran Medical Technology 1, Inc.
Sources (1)
- FDA 510(k) K920332 24 fields · synced Sep 27, 2026