aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8
FDA 510(k) clearance K210883 · decided 2021-06-17
Clearance details
- K-number
- K210883
- Device name
- aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8
- Applicant
- Ambu A/S
- Decision
- Substantially Equivalent
- Date received
- 2021-03-25
- Decision date
- 2021-06-17
- Days to decision
- 84 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.