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Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2 - Ambu aView Monitor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K173727

by Ambu A/S

Identifiers

510(k) Number
K173727 FDA 510(k)
FDA Product Code
EOQ FDA 510(k)
Models / Variants
Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2 FDA 510(k)
Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2 FDA 510(k)
Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8 FDA 510(k)
Ambu aView Monitor FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 874.4680 FDA 510(k)
Regulation Number
874.4680 FDA 510(k)
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2 - Ambu aView Monitor by Ambu A/S — Class II — FDA_510K — listed in FDA 510(k) — 4 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ambu A/S

Sources (1)

  • FDA 510(k) K173727 24 fields · synced Jun 18, 2026