NJJ · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.1930
Classification
FDA Product Code
NJJ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 886.1930
Review panel
OP
Medical specialty
Ophthalmic
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.