FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor
K Number: K183492
·
Decision Mar 13, 2019
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
130
Applicant Total
8
Review Days
86
Basic Information
- Device Name
- JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor
- K Number
- K183492
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nanjing Jusha Display Technology Co., Ltd.
- Date Received
- December 17, 2018
- Decision Date
- March 13, 2019
- Product Code
- PGY
- 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 |
|---|---|---|---|
| PGY | Display, Diagnostic Radiology | FDA class 2 | Radiology |
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Other Clearances by Nanjing Jusha Display Technology Co., Ltd.
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|---|---|---|---|
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