FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Ultrasound Transmission Gels
K Number: K221999
·
Decision Aug 30, 2022
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
33
Applicant Total
4
Review Days
54
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Basic Information
- Device Name
- Ultrasound Transmission Gels
- K Number
- K221999
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hony Medical Co., Ltd.
- Date Received
- July 7, 2022
- Decision Date
- August 30, 2022
- Product Code
- MUI
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| MUI | Media, Coupling, Ultrasound | FDA class 2 | Radiology |
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