FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2
K Number: K842754
·
Decision Nov 28, 1984
Classifications
1
FEI Numbers
150
Registration Numbers
150
Same Product Code
18
Applicant Total
4
Review Days
135
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Basic Information
- Device Name
- CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2
- K Number
- K842754
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6150
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Custom Ultrasonics
- Date Received
- July 16, 1984
- Decision Date
- November 28, 1984
- Product Code
- FLG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FLG | Cleaner, Ultrasonic, Medical Instrument | FDA class 1 | General Hospital |
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