FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENDOSCOPIC CAMERA TV W/AUDIO
K Number: K832342
·
Decision Sep 12, 1983
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
17
Applicant Total
4
Review Days
62
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Basic Information
- Device Name
- ENDOSCOPIC CAMERA TV W/AUDIO
- K Number
- K832342
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4160
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Kamiya Tsusan Kaisha, Ltd.
- Date Received
- July 12, 1983
- Decision Date
- September 12, 1983
- Product Code
- KQM
- 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 |
|---|---|---|---|
| KQM | Camera, Surgical And Accessories | FDA class 1 | General, Plastic Surgery |
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