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