FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8
K Number: K210883
·
Decision Jun 17, 2021
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
238
Applicant Total
38
Review Days
84
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Basic Information
- Device Name
- aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8
- K Number
- K210883
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ambu A/S
- Date Received
- March 25, 2021
- Decision Date
- June 17, 2021
- Product Code
- EOQ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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| K232582 | Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set | Sep 20, 2023 | Substantially Equivalent |