Ambu® AScope™ Gastro, Ambu® ABox™2

Gastroscope And Accessories, Flexible/rigid

Ambu A/S

The following data is part of a premarket notification filed by Ambu A/s with the FDA for Ambu® Ascope™ Gastro, Ambu® Abox™2.

Pre-market Notification Details

• Device ID: K212382
• 510k Number: K212382
• Device Name: Ambu® AScope™ Gastro, Ambu® ABox™2
• Classification: Gastroscope And Accessories, Flexible/rigid
• Applicant: Ambu A/S Baltorpbakken 13 Ballerup, DK 2750
• Contact: Mette Anderson
• Correspondent: Sanjay Parikh; Ambu Inc. 6230 Old Dobbin Lane, Suite 250 Columbia, MD 21045
• Product Code: FDS
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-08-02
• Decision Date: 2022-02-03