FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
MoistureMeterD Compact, LymphScanner
K Number: K220557
·
Decision May 27, 2022
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
9
Applicant Total
2
Review Days
88
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Basic Information
- Device Name
- MoistureMeterD Compact, LymphScanner
- K Number
- K220557
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Delfin Technologies, Ltd.
- Date Received
- February 28, 2022
- Decision Date
- May 27, 2022
- Product Code
- OBH
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| OBH | Monitor, Extracellular Fluid, Lymphedema, Extremity | FDA class 2 | Cardiovascular |
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Other Clearances by Delfin Technologies, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K143310 | MoisturemeterD | Nov 19, 2015 | Substantially Equivalent |