FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
Ultrasound System 2300
K Number: K223830
·
Decision Apr 11, 2023
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
9
Review Days
111
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Basic Information
- Device Name
- Ultrasound System 2300
- K Number
- K223830
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bk Medical Aps
- Date Received
- December 21, 2022
- Decision Date
- April 11, 2023
- 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
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Other Clearances by Bk Medical Aps
| K Number | Device Name | ||
|---|---|---|---|
| K231764 | Ultrasound System 1300 | Oct 23, 2023 | Substantially Equivalent |
| K222441 | Ultrasound System 2300 | Dec 7, 2022 | Substantially Equivalent |
| K180737 | Ultrasound Scanner System bk2300 | Aug 1, 2018 | Substantially Equivalent |
| K173569 | Ultrasound System 1300 | Feb 23, 2018 | Substantially Equivalent |
| K161960 | bk2300 | Oct 17, 2016 | Substantially Equivalent |
| K151910 | Ultrasound Scanner System BK2300 | Oct 5, 2015 | Substantially Equivalent |
| K152052 | Ultrasound Scanner System bk2300 | Sep 16, 2015 | Substantially Equivalent |
| K143298 | Ultrasound Scanner System bk2300 | Jan 16, 2015 | Substantially Equivalent |