FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KOSMOS
K Number: K193518
·
Decision Mar 26, 2020
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
5
Review Days
98
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Basic Information
- Device Name
- KOSMOS
- K Number
- K193518
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EchoNous, Inc.
- Date Received
- December 19, 2019
- Decision Date
- March 26, 2020
- 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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