FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SonoFlow Sonohysterography and Sonohysterosalpingography Device
K Number: K142545
·
Decision Mar 20, 2015
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
86
Applicant Total
3
Review Days
191
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Basic Information
- Device Name
- SonoFlow Sonohysterography and Sonohysterosalpingography Device
- K Number
- K142545
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Crossbay Medical, Inc.
- Date Received
- September 10, 2014
- Decision Date
- March 20, 2015
- Product Code
- LKF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | FDA class 2 | Obstetrics/Gynecology |
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