FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYLINDER OF GAS, CAN OF GAS (CC12F2)
K Number: K921617
·
Decision Aug 5, 1992
Classifications
1
FEI Numbers
36
Registration Numbers
37
Same Product Code
57
Applicant Total
319
Review Days
121
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Basic Information
- Device Name
- CYLINDER OF GAS, CAN OF GAS (CC12F2)
- K Number
- K921617
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bio-Rad
- Date Received
- April 6, 1992
- Decision Date
- August 5, 1992
- Product Code
- HKX
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HKX | Tonometer, Ac-Powered | FDA class 2 | Ophthalmic |
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