PASCALL SYSTEMS INC

FDA Device Registration & Listing · Cambridge, MA, US · Registration 3024892936

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3024892936
FEI Number
3024892936
Entity Name
PASCALL SYSTEMS INC
City/State/Country
Cambridge, MA, US
Establishment Address
625 Mass Ave, Cambridge, MA 02139, US
Establishment Type(s)
Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Pascall Systems Inc (Owner Number: 10086400)
Owner / Operator Contact Address
625 Massachusetts Avenue, Cambridge, MA 02139, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K213299
PMA Number
N/A

All Registered Proprietary Names

Wireless EEG System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2022-11-07
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2022-11-07
ORT Burst Suppression Detection Software For Electroencephalograph Neurology Class 2 882.1400 2022-11-07
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2022-11-07

Official Correspondent

Tuan Le Mau

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pascall Systems Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K033010 Brainz Instruments , Ltd. BRM2 BRAIN MONITOR 2003-10-10
K991012 Siemens Medical Solutions USA, Inc. SIEMENS INFINITY EEG POD 1999-06-24
K852587 Tracor Northern, Inc. CDSA(COLOR DENSITY, SPECTRAL ARRRAY) 1985-08-16
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07
K123915 Grass Technologies, an Astro-Med, Inc. Product Gro DE48-PLUS 2013-04-24

Similar Registrations

Registration Number Establishment Name Location
3038281851 Philips Polska Sp. z o.o. Lodz Lodzkie, PL
3016852448 Nihon Kohden Corporation - Eastern Japan Logistics Center Sakado City Saitama, JP
3008773490 PAUL E. DANCHELL A/S Jyderup Sjalland, DK
9611252 NIHON KOHDEN CORP. SHINJUKU-KU Tokyo, JP
3009156722 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Shenzhen Guangdong, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024892936. Last updated year: 2026. Please use registration number 3024892936 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.