Atlas FDA

Ambu USR, Ambu M

FDA 510(k) clearance K160766 · decided 2016-08-17

Clearance details

K-number
K160766
Device name
Ambu USR, Ambu M
Applicant
Ambu A/S
Decision
Substantially Equivalent
Date received
2016-03-21
Decision date
2016-08-17
Days to decision
149 days
Clearance type
Traditional
Product code
FAJ
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Ballerup, DK
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.