FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Ultrasonic Mesh Nebulizer
K Number: K201397
·
Decision Jun 14, 2021
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
1
Review Days
382
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Basic Information
- Device Name
- Ultrasonic Mesh Nebulizer
- K Number
- K201397
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Ivankaca Technology Co., Ltd.
- Date Received
- May 28, 2020
- Decision Date
- June 14, 2021
- Product Code
- CAF
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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