FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LT-300 SD Digital Video Colposcope
K Number: K170446
·
Decision May 21, 2017
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
55
Applicant Total
4
Review Days
96
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Basic Information
- Device Name
- LT-300 SD Digital Video Colposcope
- K Number
- K170446
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1630
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lutech Industries, Inc.
- Date Received
- February 14, 2017
- Decision Date
- May 21, 2017
- 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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