510(k) K230332
- Device
- Ambu® aScope? Colon; Ambu® aBox? 2
- Applicant
- Ambu A/S
- 510(k) number
- K230332
- Product code
- FDF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-15
- Date received
- 2023-02-07
- Regulation
- 876.1500
- Classification name
- Colonoscope And Accessories, Flexible/Rigid
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Mette Andersen
- Address
- Baltorpbakken 13 Ballerup DK 2750 2750
FDA Registration Numbers
- 3009698186
- 3024021261
- 3018258446
- 2528981
- 3004705634
- 3014605202
- 3010288205
- 3021008900
- 1651395
- 3015525240
- 3013505983
- 3002807314
- 3042225166
- 1000121056
- 3011416394
- 3011816755
- 8010047
- 3011050570
- 3010202439
- 1047843
- 2011171
- 3006161756
- 3004052101
- 3028058843
- 2950776
- 9616684
- 1220477
- 3010703925
- 3005261802
- 3010229237
- 9611112
- 1221826
- 3008386005
- 3004111573
- 3042172882
- 3003775006
- 2020550
- 3002808148
- 3013944123
- 9610595
- 3014769442
- 3006546082
- 3013184907
- 2246552
- 3012414760
- 3004644065
- 3004016520
- 3002808022
- 3005099803
- 3021246306
- 9614641
- 3023102955
- 9611680
- 3012843412
- 1528319
- 3015451828
- 3005814162
- 9681260
- 3015136743
- 3022106566
- 3017210488
- 3008797804
- 3008879776
- 3015746529
- 9610877
- 3010390468
- 3010707607
- 3003637092
- 9610617
- 3003782610
- 3010009693
- 3014342096
- 3020707080
- 3014279513
- 3009420598
- 1222928
- 3013023255
Source Documents
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