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Salterlabs 8660 Series Nebulizer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K962879

by Salter Labs

Identifiers

510(k) Number
K962879 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)

Salterlabs 8660 Series Nebulizer by Salter Labs — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Salter Labs

Sources (1)

  • FDA 510(k) K962879 24 fields · synced Jun 18, 2026