FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OCULAR CEREBRAL VASCULAR MONITOR
K Number: K772130
·
Decision Nov 28, 1977
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
55
Applicant Total
1
Review Days
17
Basic Information
- Device Name
- OCULAR CEREBRAL VASCULAR MONITOR
- K Number
- K772130
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- DIGILAB, INC.
- Date Received
- November 11, 1977
- Decision Date
- November 28, 1977
- Product Code
- HKY
- 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 |
|---|---|---|---|
| HKY | Tonometer, Manual | FDA class 2 | Ophthalmic |
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