← Back to catalogue

Salter Labs 8960 Series Nebulizer (8960/8961/8966/8984)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K961476

by Salter Labs

Identifiers

510(k) Number
K961476 FDA 510(k)
FDA Product Code
CAF FDA 510(k)
Models / Variants
8960 FDA 510(k)
8961 FDA 510(k)
8966 FDA 510(k)
8984 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)

The Salter Labs 8960 Series Nebulizer is a Nebulizer (Direct Patient Interface) designed to deliver aerosolized medication to patients via inhalation. These devices convert liquid medication into a fine mist for efficient lung deposition, commonly used in respiratory therapy for conditions requiring inhaled treatments. The series includes variations such as the Model 8960, which incorporates an expiration valve in its mouthpiece to enhance user control during inhalation.

The 8960 Series Nebulizer is intended for single-use or reusable applications in clinical settings, including hospitals and outpatient care. It is classified under FDA product code CAF and holds a FDA 510(k) clearance (K961476) as substantially equivalent to a predicate device, with review by the Anesthesiology Advisory Committee. Sterility and regulatory compliance are ensured through manufacturer specifications, though specific storage conditions or reprocessing instructions are not detailed in the available data.

Frequently asked questions

What is the Salter Labs 8960 Series Nebulizer used for?

The Salter Labs 8960 Series Nebulizer is designed to convert liquid medication into a fine mist for inhalation therapy. This makes it ideal for delivering aerosolized treatments directly to the lungs, commonly used in respiratory care for conditions requiring inhaled medications. The series includes variations like the Model 8960, which features an expiration valve in the mouthpiece to improve user control during inhalation.

How is the Salter Labs 8960 Series Nebulizer supplied, and is it single-use or reusable?

The Salter Labs 8960 Series Nebulizer is intended for use in clinical settings, including hospitals and outpatient care, and can be used either as a single-use or reusable device. The manufacturer ensures sterility and regulatory compliance, though specific reprocessing instructions or storage conditions are not detailed in the available data. Clinicians should follow established facility protocols for cleaning and sterilization if reusing.

What distinguishes the different models in the 8960 Series Nebulizer?

The 8960 Series includes multiple models (8960, 8961, 8966, and 8984), with the primary distinction being functional features. For example, the Model 8960 incorporates an expiration valve in its mouthpiece, which helps users regulate airflow during inhalation. Other models may vary in design or additional features, but the core purpose remains delivering aerosolized medication efficiently.

Does the Salter Labs 8960 Series Nebulizer require special storage conditions?

The available data does not specify exact storage conditions for the Salter Labs 8960 Series Nebulizer. However, as with most medical devices, it is recommended to store it in a clean, dry environment, protected from direct sunlight and extreme temperatures. If the device is reusable, adherence to facility-specific reprocessing protocols is essential to maintain sterility and functionality.

What regulatory approval does the Salter Labs 8960 Series Nebulizer hold?

The Salter Labs 8960 Series Nebulizer holds FDA 510(k) clearance (K961476) as substantially equivalent to a predicate device. This clearance was reviewed by the Anesthesiology Advisory Committee and classified under product code CAF. The device meets FDA requirements for safety and effectiveness as a Nebulizer (Direct Patient Interface).

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: Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984), K961476 - Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984), SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Salter Labs

Sources (1)

  • FDA 510(k) K961476 24 fields · synced Oct 1, 2026