Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance
FDA 510(k) clearance K233671 · decided 2024-01-04
Clearance details
- K-number
- K233671
- Device name
- Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance
- Applicant
- Ambu A/S
- Decision
- Substantially Equivalent
- Date received
- 2023-11-15
- Decision date
- 2024-01-04
- Days to decision
- 50 days
- Clearance type
- Special
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Ballerup, DK
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.