CLINICAL COMPUTER SYSTEMS, INC.

FDA Device Registration & Listing · Hoffman Est, IL, US · Registration 3004423584

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
3004423584
FEI Number
3004423584
Entity Name
CLINICAL COMPUTER SYSTEMS, INC.
City/State/Country
Hoffman Est, IL, US
Establishment Address
2895 Greenspoint Pkwy, Suite 650, Hoffman Est, IL 60169, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
CLINICAL COMPUTER SYSTEMS, INC. (Owner Number: 9070701)
Owner / Operator Contact Address
2895 Greenspoint Parkway, Suite 650, --, Hoffman Estates, IL 60169, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K121208
PMA Number
N/A

All Registered Proprietary Names

OBIX

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HGM System, Monitoring, Perinatal Obstetrics/Gynecology Class 2 884.2740 2014-10-30

Official Correspondent

Kerry Armstrong

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CLINICAL COMPUTER 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
K771196 Hewlett-Packard Co. MARKER GENERATOR MODULES - 21597A 1977-08-03
K813458 Cranbury Medical Labs, Inc. FETASCAN 1000, 1000A OBSTETRICAL DATA 1982-01-28
K100420 Philips Medizin Systeme Boeblingen GmbH PHILIPS OBTRACEVUE MODEL SW REV. G.00 2010-07-26
K173941 Philips Medizin Systeme Boeblingen GmbH IntelliSpace Perinatal Rev.K.00 2018-09-10
K062137 Philips Medizin Systeme Boeblingen GmbH MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30 2006-08-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0035-06 N/A 2
FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
Z-0036-06 N/A 2
FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004423584. Last updated year: 2026. Please use registration number 3004423584 when referencing this establishment in official correspondence.
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