FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Video Colposcope
K Number: K151878
·
Decision Dec 1, 2015
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
55
Applicant Total
47
Review Days
145
Basic Information
- Device Name
- Video Colposcope
- K Number
- K151878
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1630
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EDAN INSTRUMENTS, INC.
- Date Received
- July 9, 2015
- Decision Date
- December 1, 2015
- Product Code
- HEX
- 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 |
|---|---|---|---|
| HEX | Colposcope (And Colpomicroscope) | FDA class 2 | Obstetrics/Gynecology |
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|---|---|---|---|
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| K153475 | SD5 & SD6 Ultrasonic Tabletop Doppler | Jan 29, 2016 | Substantially Equivalent |
| K151787 | Holter System | Jan 27, 2016 | Substantially Equivalent |
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