FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUANTUM 412
K Number: K844570
·
Decision Dec 5, 1984
Classifications
1
FEI Numbers
66
Registration Numbers
67
Same Product Code
40
Applicant Total
3
Review Days
12
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Basic Information
- Device Name
- QUANTUM 412
- K Number
- K844570
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1605
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Keta Corp.
- Date Received
- November 23, 1984
- Decision Date
- December 5, 1984
- Product Code
- HPT
- 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 |
|---|---|---|---|
| HPT | Perimeter, Automatic, Ac-Powered | FDA class 1 | Ophthalmic |
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