DeviceClearance

Product code NJJ— Ophthalmic

BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01

Classification name
Tonometer, Analyzer, Ocular Blood Flow
Device class
Class 2
Regulation
21 CFR 886.1930
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code NJJ under 21 CFR 886.1930, via openFDA

Market context for product code NJJ

FDA has cleared 1 device under product code NJJ, all in 2002, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NJJ

Recent clearances under product code NJJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.