← Back to catalogue

ResScan Essentials

FDA 510(k)

Class II (US FDA 510(k))

510(k) K254104

by Resmed Corp

Identifiers

510(k) Number
K254104 FDA 510(k)
FDA Product Code
BZD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5905 FDA 510(k)
Regulation Number
868.5905 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

ResScan Essentials by Resmed Corp — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

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
Resmed Corp

Sources (1)

  • FDA 510(k) K254104 24 fields · synced Jun 19, 2026