Ambu Duodeno System
FDA 510(k) clearance K201098 · decided 2020-07-17
Clearance details
- K-number
- K201098
- Device name
- Ambu Duodeno System
- Applicant
- Ambu Innovation GmbH
- Decision
- Substantially Equivalent
- Date received
- 2020-04-24
- Decision date
- 2020-07-17
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- FDT
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Kissing, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.