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 IDK212382
510k NumberK212382
Device Name:Ambu® AScope™ Gastro, Ambu® ABox™2
ClassificationGastroscope And Accessories, Flexible/rigid
Applicant Ambu A/S Baltorpbakken 13 Ballerup,  DK 2750
ContactMette Anderson
CorrespondentSanjay Parikh
Ambu Inc. 6230 Old Dobbin Lane, Suite 250 Columbia,  MD  21045
Product CodeFDS  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-02
Decision Date2022-02-03

Trademark Results [Ambu]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AMBU
AMBU
98192535 not registered Live/Pending
AMBU A/S
2023-09-22
AMBU
AMBU
90002202 not registered Live/Pending
AMBU
2020-06-15
AMBU
AMBU
79051291 3554442 Live/Registered
AMBU A/S
2008-02-15
AMBU
AMBU
74156351 1686178 Live/Registered
AMBU A/S
1991-04-12
AMBU
AMBU
73438330 1330624 Dead/Cancelled
Testa-Laboratorium A/S
1983-08-08
AMBU
AMBU
73023700 1040868 Dead/Expired
TESTA-LABORATORIUM A/S
1974-06-10
AMBU
AMBU
72127671 0740102 Dead/Cancelled
Testa Laboratorium A/S
1961-09-11
AMBU
AMBU
72055090 0705020 Dead/Cancelled
TESTA LABORATORIUM A/S
1958-07-10

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