FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER
K Number: K991840
·
Decision Mar 20, 2000
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
55
Applicant Total
1
Review Days
297
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER
- K Number
- K991840
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bernard B. Fresco
- Date Received
- May 28, 1999
- Decision Date
- March 20, 2000
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HKY), ordered by most recent decision date.
iCare ST500 (TA04)
FDA 510(k)
FDA Class 2
·Ophthalmic
Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)
FDA 510(k)
FDA Class 2
·Ophthalmic
CATS-L Tonometer Prism
FDA 510(k)
FDA Class 2
·Ophthalmic
Applanation Tonometer HT-5000
FDA 510(k)
FDA Class 2
·Ophthalmic
iCare IC200
FDA 510(k)
FDA Class 2
·Ophthalmic
iCare HOME2
FDA 510(k)
FDA Class 2
·Ophthalmic