NJJ — Tonometer, Analyzer, Ocular Blood Flow Class II
FDA product code NJJ covers "Tonometer, Analyzer, Ocular Blood Flow", a Class II medical device regulated under 21 CFR 886.1930. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NJJ
- Device Class
- Class II
- Regulation Number
- 886.1930
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K023245 | paradigm medical industries | BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01 | October 21, 2002 |