FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Falck Medical Multifunction Tonometer, FAT1
K Number: K151491
·
Decision Jan 15, 2016
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
55
Applicant Total
1
Review Days
226
Basic Information
- Device Name
- Falck Medical Multifunction Tonometer, FAT1
- K Number
- K151491
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FALCK MEDICAL, INC
- Date Received
- June 3, 2015
- Decision Date
- January 15, 2016
- 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