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

Physiological Signal Based Seizure Monitoring System

21 CFR 882.1580 / Neurology
FDA source (opens on fda.gov)

POS is the FDA product code for Physiological Signal Based Seizure Monitoring System, a class II device type, regulated under 21 CFR 882.1580. FDA's definition for this code reads: "The Physiological signal based seizure monitoring system is a prescription device that uses physiological signal to identify abnormal physiological activity that may be associated with a seizure. The System does not predict seizure onsets, and is not intended as a standalone seizure monitoring device". As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
POS
Device name
Physiological Signal Based Seizure Monitoring System
FDA definition
The Physiological signal based seizure monitoring system is a prescription device that uses physiological signal to identify abnormal physiological activity that may be associated with a seizure. The System does not predict seizure onsets, and is not intended as a standalone seizure monitoring device.
Regulation
21 CFR 882.1580
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
10
Ingested recalls
1

Clearances, product code POS

By decision year
10 clearances under product code POS with a decision year between 2017 and 2025, 2025 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code POS by decision year
YearClearances
20171
20182
20191
20211
20241
20254

Applicants with the most clearances

Product code POS
Applicants holding the most 510(k) clearances under product code POS
ApplicantClearances
EMPATICA S.r.l.4
Brain Sentinel, Inc.2
EpiWatch, Inc.1
Lgch, Inc.1
Livassured1
Neuro Event Labs Oy1

Companies listing this code with FDA

Companies whose registered establishments list this code