Device
The single use patch M0P, part of the Wireless EEG System.
Manufacturer
PASCALL SYSTEMS, INC.
PASCALL SYSTEMS, INC.
Model: M0P
DI: 00860014334313
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
The single use patch M0P, part of the Wireless EEG System.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d15636f6-2f93-4ed2-8bb7-c2ca2eb46a0a
Distribution Status:
In Commercial Distribution
DUNS Number:
116842769
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860014334313
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 38736
Name: Electroencephalographic monitoring system
Definition:
An electrically-powered device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function, typically in an examination room or intensive care unit (ICU) [bedside]; it may also monitor additional physiological parameters [e.g., electromyogram (EMG), respiration wave forms, blood pressure, haemoglobin oxygen saturation (SpO2)] in relation to EEG. It typically includes a control unit, electrodes, and components (e.g., amplifier, cables, probes). It may include data interpretation and/or telemetry features.
FDA Product Codes
GXY
Electrode, Cutaneous
Premarket Submissions
Submission Number:
K213299
Supplement Number:
000