FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KY-M280U SURGICAL CAMERA
K Number: K854988
·
Decision Jan 24, 1986
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
2
Applicant Total
1
Review Days
43
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Basic Information
- Device Name
- KY-M280U SURGICAL CAMERA
- K Number
- K854988
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4160
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Us Jvc Corp.
- Date Received
- December 12, 1985
- Decision Date
- January 24, 1986
- Product Code
- FWC
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FWC | Camera, Television, Surgical, With Audio | FDA class 1 | General, Plastic Surgery |
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