Tonometer, Analyzer, Ocular Blood Flow
The Ocular Blood Flow Tonometer Analyzer is an ophthalmic device that measures and records intraocular pressure, intraocular pulse amplitudes, pulsatile ocular blood flow, pulsatile ocular blood volume, and pulsatility index, combining standard tonometry with the capability to analyze ocular blood flow parameters derived from the ocular arterial pulse. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NJJ and regulation 21 CFR 886.1930 in the Ophthalmic specialty. The device is eligible for third-party review and carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NJJ
- Device Class
- FDA class 2
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
Definition
Tonometry for measuring and recording intraocular pressures and intraocular pulse amplitudes, pulsatile ocular blood flow, pulsatile ocular blood volume, pulsatility index equivalent. Description of why current product c lassificaiton name/product code will not suffice: This device measures intraocular pressure, which is what a tonometer does. However, because it can measure the small changes in pressure caused by the blood pressure pulse in the ocular arterial vessels, it is also capable of measuring and calculating parameters associated with the ocular blood flow, including intraocular pressure pulse amplitude, pulsatile ocular blood flow, and pulsatile ocular blood volume.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K023245 | BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01 | Oct 21, 2002 | Substantially Equivalent | Paradigm Medical Industries, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.