PASCALL SYSTEMS, INC.

Primary DI
00860014334313
Brand
PASCALL SYSTEMS, INC.
Company
PASCALL SYSTEMS, INC.
Model
M0P
Device description
The single use patch M0P, part of the Wireless EEG System.
Published
2026-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213299000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213299000Wireless EEG SystemPascall Systems, Inc.2022-05-11OLT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014334313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014334313008600143343138600143343130860014334313

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic monitoring systemAn 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.

Contacts#

Phone, Email table
PhoneEmail
(617) 982 4274tuan@pascallsystems.com

Regulatory Flags#

DUNS number
116842769
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014334320PASCALL SYSTEMS, INC.PSU12026-09-04
00860014334306PASCALL SYSTEMS, INC.M0S2026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00382830063883NatusXLTEKGXY2026-10-15
00382830063890NatusXLTEKGXY2026-10-15
00382830063906NatusXLTEKGXY2026-10-15
00382830063913NatusXLTEKGXY2026-10-15
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08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
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