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

Standard Polysomnograph With Electroencephalograph

21 CFR 882.1400 / Neurology
FDA source (opens on fda.gov)

OLV is the FDA product code for Standard Polysomnograph With Electroencephalograph, a class II device type, regulated under 21 CFR 882.1400. FDA's definition for this code reads: "Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data". As of , FDA records hold 65 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OLV
Device name
Standard Polysomnograph With Electroencephalograph
FDA definition
Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
65
Ingested recalls
1

Clearances, product code OLV

By decision year
65 clearances under product code OLV with a decision year between 1986 and 2026, 1999 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code OLV by decision year
YearClearances
19863
19942
19973
19985
19997
20005
20014
20027
20031
20043
20054
20082
20101
20112
20131
20151
20173
20183
20202
20221
20242
20251
20262

Applicants with the most clearances

Product code OLV
Applicants holding the most 510(k) clearances under product code OLV
ApplicantClearances
Nihon Kohden America Inc9
Neurotronics, LLC5
Grass-Telefactor Product Group4
Bio-Logic Systems Corp.3
Airsep Corp.2
Astro-Med, Inc.2
Biosys AB (Publ)2
Compumedics Limited2
Excel Tech., Ltd.2
Grass Instrument Co.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 45 companies shown, in name order