FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXALT Model B Single-Use Bronchoscope
K Number: K222014
·
Decision Jul 28, 2022
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
238
Applicant Total
231
Review Days
20
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Basic Information
- Device Name
- EXALT Model B Single-Use Bronchoscope
- K Number
- K222014
- 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
- Boston Scientific Corporation
- Date Received
- July 8, 2022
- Decision Date
- July 28, 2022
- 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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