FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LOGIQ E10s, LOGIQ Fortis
K Number: K211524
·
Decision Aug 27, 2021
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
168
Review Days
102
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Basic Information
- Device Name
- LOGIQ E10s, LOGIQ Fortis
- K Number
- K211524
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE Healthcare
- Date Received
- May 17, 2021
- Decision Date
- August 27, 2021
- Product Code
- IYN
- 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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
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FDA 510(k)
FDA Class 2
·Radiology
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