FDA.reportPublic FDA data

PASCALL SYSTEMS, INC.

Primary DI
00860014334320
Brand
PASCALL SYSTEMS, INC.
Company
PASCALL SYSTEMS, INC.
Model
PSU1
Device description
Pascall Sensor Unit 1 (PSU1) Wireless EEG System.
Published
2026-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous
OLTNon-Normalizing Quantitative Electroencephalograph Software
OMCReduced- Montage Standard Electroencephalograph
ORTBurst Suppression Detection Software For Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2
OMCReduced- Montage Standard ElectroencephalographNeurology2
ORTBurst Suppression Detection Software For ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K254213000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254213000Pascall Sensor Unit (PSU1)Pascall Systems, Inc.2026-08-19OLT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014334320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014334320008600143343208600143343200860014334320

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014334306PASCALL SYSTEMS, INC.M0S2026-05-19
00860014334313PASCALL SYSTEMS, INC.M0P2026-05-19

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