FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FALCON
K Number: K111416
·
Decision Jul 15, 2011
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
71
Applicant Total
6
Review Days
56
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Basic Information
- Device Name
- FALCON
- K Number
- K111416
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2880
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Viasonix , Ltd.
- Date Received
- May 20, 2011
- Decision Date
- July 15, 2011
- Product Code
- JOP
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| JOP | Transducer, Ultrasonic | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K192607 | LiteWalk | Dec 19, 2019 | Substantially Equivalent |
| K191023 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX | May 16, 2019 | Substantially Equivalent |
| K170859 | Dolphin/IQ and Dolphin/4D | Nov 14, 2017 | Substantially Equivalent |