FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EchoMark, EchoMark LP
K Number: K180621
·
Decision Jun 6, 2018
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
109
Applicant Total
3
Review Days
89
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Basic Information
- Device Name
- EchoMark, EchoMark LP
- K Number
- K180621
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sonavex, Inc.
- Date Received
- March 9, 2018
- Decision Date
- June 6, 2018
- Product Code
- NEU
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| NEU | Marker, Radiographic, Implantable | FDA class 2 | General, Plastic Surgery |
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