PeriGen Solutions Ltd.

FDA Device Registration & Listing · Rishon LeTziyon Central, IL · Registration 9615396

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
9615396
FEI Number
3002687025
Entity Name
PeriGen Solutions Ltd.
City/State/Country
Rishon LeTziyon Central, IL
Establishment Address
Azriel Rishonim, 10th Floor, Sderot Nim2, Rishon LeTziyon, Rishon LeTziyon Central 7510002, IL
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
PeriGen, Inc. (Owner Number: 10030146)
Owner / Operator Contact Address
100 Regency Forest Drive, Suite 200, Cary, NC 27518, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K241009
PMA Number
N/A

All Registered Proprietary Names

PeriCALM CheckList PeriWatch Cues PeriCALM Patterns PeriGen Visual Cueing PeriWatch Curve PeriWatch Vigilance Curve PeriCALM Curve PeriGen Decision Support Technologies PeriCALM Patterns 3

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 2009-08-19
HGM System, Monitoring, Perinatal Obstetrics/Gynecology Class 2 884.2740 2009-08-19
HGM System, Monitoring, Perinatal Obstetrics/Gynecology Class 2 884.2740 2025-01-16

Official Correspondent

No official correspondent registered.

US Agent Details

Matthew Sappern Business: Perigen Inc. Email: matthew.sappern@perigen.com Phone: (984) 2094250

Related Public Records

Same Entity

PeriGen, 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 9615396. Last updated year: 2026. Please use registration number 9615396 when referencing this establishment in official correspondence.
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