FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)
K Number: K213497
·
Decision Nov 15, 2021
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
4
Review Days
14
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Basic Information
- Device Name
- ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)
- K Number
- K213497
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- H&abyz Co., Ltd.
- Date Received
- November 1, 2021
- Decision Date
- November 15, 2021
- Product Code
- MQB
- 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 |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
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