FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
21.3 5MP Color LCD Display UMD5-21B01
K Number: K241499
·
Decision Jun 13, 2024
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
134
Applicant Total
2
Review Days
16
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Basic Information
- Device Name
- 21.3 5MP Color LCD Display UMD5-21B01
- K Number
- K241499
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acula Technology Corp.
- Date Received
- May 28, 2024
- Decision Date
- June 13, 2024
- Product Code
- PGY
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
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 Acula Technology Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K233336 | 21.3 3MP Color LCD Display UMD3-21B01 (MD3-21B01) | May 21, 2024 | Substantially Equivalent |