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

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

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

OLZ is the FDA product code for Automatic Event Detection Software For Polysomnograph With Electroencephalograph, a class II device type, regulated under 21 CFR 882.1400. FDA's definition for this code reads: "Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All...". As of , FDA records hold 37 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OLZ
Device name
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
FDA definition
Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user
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
No
Ingested clearances
37
Ingested recalls
0

Clearances, product code OLZ

By decision year
37 clearances under product code OLZ with a decision year between 1986 and 2026, 2025 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code OLZ by decision year
YearClearances
19861
19871
19892
19901
19921
19972
20001
20041
20071
20111
20121
20131
20152
20163
20172
20181
20192
20201
20211
20221
20232
20242
20254
20262

Applicants with the most clearances

Product code OLZ
Applicants holding the most 510(k) clearances under product code OLZ
ApplicantClearances
Advanced Brain Monitoring, Inc.3
Beacon Biosignals, Inc.3
Embla Systems3
Respironics, Inc.3
Ensodata, Inc.2
Honeynaps Co., Ltd.2
Micro Tronics Corp.2
Nox Medical Ehf2
Oxford Medilog, Inc.2
Biologic Systems Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order