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Mod. 4006 Adu., Oxy. Delive.-Oral Co2 Sam. Cannula

FDA 510(k)

Class II (US FDA 510(k))

510(k) K864903

by Salter Labs

Identifiers

510(k) Number
K864903 FDA 510(k)
FDA Product Code
CCK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1400 FDA 510(k)
Regulation Number
868.1400 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Mod. 4006 Adu., Oxy. Delive.-Oral Co2 Sam. Cannula 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) K864903 24 fields · synced Jun 19, 2026