K-number	K232919
Device name	Ambu® aScope Gastro Large; Ambu® aBox 2
Applicant	Ambu A/S
Product code	FDS
Device class	Class II
Decision date	Apr 5, 2024
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Ambu® aScope Gastro Large; Ambu® aBox 2

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Ambu® aScope Gastro Large; Ambu® aBox 2