Ambu® aScope™ Colon; Ambu® aBox™ 2
FDA 510(k) clearance K230332 · decided 2023-09-15
Clearance details
- K-number
- K230332
- Device name
- Ambu® aScope™ Colon; Ambu® aBox™ 2
- Applicant
- Ambu A/S
- Decision
- Substantially Equivalent
- Date received
- 2023-02-07
- Decision date
- 2023-09-15
- Days to decision
- 220 days
- Clearance type
- Traditional
- Product code
- FDF
- 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.