FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHAIN SILENCER
K Number: K823873
·
Decision Jan 14, 1983
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
63
Applicant Total
6
Review Days
17
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Basic Information
- Device Name
- CHAIN SILENCER
- K Number
- K823873
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3920
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Berkeley Electric Wheelchair Co.
- Date Received
- December 28, 1982
- Decision Date
- January 14, 1983
- Product Code
- KNN
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| KNN | Components, Wheelchair | FDA class 1 | Physical Medicine |
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Other Clearances by Berkeley Electric Wheelchair Co.
| K Number | Device Name | ||
|---|---|---|---|
| K823085 | BERKELEY CHAIR | Jan 21, 1983 | Substantially Equivalent |
| K823877 | BERKELEY HARNESS | Jan 14, 1983 | Substantially Equivalent |
| K823874 | BERKELEY BRAKE | Jan 14, 1983 | Substantially Equivalent |
| K823876 | BERKELEY FORK | Jan 14, 1983 | Substantially Equivalent |
| K823875 | CHAIN KIT | Jan 14, 1983 | Substantially Equivalent |