Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance
FDA 510(k) clearance K223299 · decided 2023-06-01
Clearance details
- K-number
- K223299
- Device name
- Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance
- Applicant
- Ambu A/S
- Decision
- Substantially Equivalent
- Date received
- 2022-10-27
- Decision date
- 2023-06-01
- Days to decision
- 217 days
- Clearance type
- Traditional
- 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2 recall (Z-0714-2024) | Ambu Inc. | 2024-01-11 |