FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TIP & MEMBRANE ASSEMBLY
K Number: K921443
·
Decision Jun 22, 1993
Classifications
1
FEI Numbers
36
Registration Numbers
37
Same Product Code
57
Applicant Total
319
Review Days
483
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Basic Information
- Device Name
- TIP & MEMBRANE ASSEMBLY
- K Number
- K921443
- 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
- February 25, 1992
- Decision Date
- June 22, 1993
- 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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