510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LLNClass I

Device, Vibration Threshold Measurement

21 CFR 882.1200 / Neurology
FDA source (opens on fda.gov)

LLN is the FDA product code for Device, Vibration Threshold Measurement, a class I device type, regulated under 21 CFR 882.1200. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LLN
Device name
Device, Vibration Threshold Measurement
Regulation
21 CFR 882.1200
Device class
Class I
Review panel
Neurology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
13
Ingested recalls
0

Clearances, product code LLN

By decision year
13 clearances under product code LLN with a decision year between 1984 and 2009, 1997 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LLN by decision year
YearClearances
19841
19862
19871
19922
19941
19973
20011
20031
20091

Applicants with the most clearances

Product code LLN
Applicants holding the most 510(k) clearances under product code LLN
ApplicantClearances
Eare Consulting Service1
Medoc Ltd. Advanced Medical Systems1
Neuro-Diagnostic Assoc.1
Neurotron Inc1
Nk Biotechnical Engineering Co.1
Osachi Co., Ltd.1
Pentax Precision Instrument Corp.1
Sensortek, Inc.1
Somedic AB1
Teca, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code