FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCUPEN
K Number: K083377
·
Decision Jul 27, 2009
Classifications
1
FEI Numbers
36
Registration Numbers
37
Same Product Code
57
Applicant Total
3
Review Days
255
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
- ACCUPEN
- K Number
- K083377
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Accutome Ultrasound, Inc.
- Date Received
- November 14, 2008
- Decision Date
- July 27, 2009
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HKX), ordered by most recent decision date.
AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
FDA 510(k)
FDA Class 2
·Ophthalmic
VS Tabletop Tonometer
FDA 510(k)
FDA Class 2
·Ophthalmic
Intraocular Pressure Tonometer EASYTON
FDA 510(k)
FDA Class 2
·Ophthalmic
MiiS Horus Scope DPT 100
FDA 510(k)
FDA Class 2
·Ophthalmic
Keeler TonoCare Tonometer
FDA 510(k)
FDA Class 2
·Ophthalmic
Tono Vue Non-Contact Tonometer
FDA 510(k)
FDA Class 2
·Ophthalmic