FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLAUKON
K Number: K820751
·
Decision Apr 9, 1982
Classifications
1
FEI Numbers
36
Registration Numbers
37
Same Product Code
57
Applicant Total
4
Review Days
21
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Basic Information
- Device Name
- GLAUKON
- K Number
- K820751
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Sonometrics Systems, Inc.
- Date Received
- March 19, 1982
- Decision Date
- April 9, 1982
- 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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