FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL IOP MONITOR
K Number: K863235
·
Decision Sep 25, 1986
Classifications
1
FEI Numbers
36
Registration Numbers
37
Same Product Code
57
Applicant Total
17
Review Days
35
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Basic Information
- Device Name
- SURGICAL IOP MONITOR
- K Number
- K863235
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Ameritek, Inc.
- Date Received
- August 21, 1986
- Decision Date
- September 25, 1986
- 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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