Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set
FDA 510(k) clearance K223782 · decided 2023-01-12
Clearance details
- K-number
- K223782
- Device name
- Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set
- Applicant
- Ambu A/S
- Decision
- Substantially Equivalent
- Date received
- 2022-12-16
- Decision date
- 2023-01-12
- Days to decision
- 27 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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Recalls involving this device
No recalls on record reference this clearance.