Device Listing 1043473386

Listing Summary

Listing key
1043473386
Premarket submission
K250269
Device
Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)
Applicant
Ambu A/S
Product code
FAJ
Decision date
2025-06-11

Related Registrations

Registration keyRegistrationFEICompanyStatusInitial importerExpirationAddress
8035996106913002806359Ambu A/S1N2026-01-01Baltorpbakken 13 Ballerup Hovedstaden DK DK-2750
3987030040403973004040397Sanjay Parikh1N2026-01-016721 Columbia Gateway Drive, Suite 200 Columbia MD US 21046