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NJJClass II

Tonometer, Analyzer, Ocular Blood Flow

21 CFR 886.1930 / Ophthalmic
FDA source (opens on fda.gov)

NJJ is the FDA product code for Tonometer, Analyzer, Ocular Blood Flow, a class II device type, regulated under 21 CFR 886.1930. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NJJ
Device name
Tonometer, Analyzer, Ocular Blood Flow
FDA 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.
Regulation
21 CFR 886.1930
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code NJJ

By decision year
1 clearance under product code NJJ with a decision year between 2002 and 2002, 2002 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NJJ by decision year
YearClearances
20021

Applicants with the most clearances

Product code NJJ
Applicants holding the most 510(k) clearances under product code NJJ
ApplicantClearances
Paradigm Medical Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code