Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004167720

FEI Number

3004167720

Entity Name

CETRO AMERICA

City/State/Country

Meriden, CT, US

Establishment Address

33 Charles Street, Meriden, CT 06450, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

CETRO AMERICA (Owner Number: 9057995)

Owner / Operator Contact Address

33 Charles Street, Meriden, CT 06450, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K911657

PMA Number

N/A

All Registered Proprietary Names

ULTRASONIC Transducer Model 8031012 TOCO Transducer Model 8032026 ULTRASONIC Transducer Model 8031014 ULTRASONIC Transducer Model 8031039 ULTRASONIC Transducer Model 8031013 ULTRASONIC Transducer Model 8031017 TOCO Transducer Model 8032025 TOCO Transducer Model 8032009 ULTRASONIC Transducer Model 8031010 ULTRASONIC Transducer Model 8031040 TOCO Transducer Model 8032010 TOCO Transducer Model 8032008 TOCO Transducer Model 8032007 ULTRASONIC Transducer Model 8031011

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	2007-12-28
HGP	Electrode, Circular (Spiral), Scalp And Applicator	Obstetrics/Gynecology	Class 2	884.2675	2022-08-26

Official Correspondent

MAYA CIANCIOLO

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CETRO AMERICA

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)

Similar Registrations

Registration Number	Establishment Name	Location
3008403701	TENACORE LLC	Costa Mesa, CA, US
3009499478	EDAN Diagnostics, Inc.	San Diego, CA, US
1424263	Isomedix Operations, Inc.	Libertyville, IL, US
3007734888	WIPRO GE HEALTHCARE PRIVATE Ltd.	BANGALORE Karnataka, IN
3007607999	TIOGA LIMITED	DERBY Derbyshire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004167720. Last updated year: 2026. Please use registration number 3004167720 when referencing this establishment in official correspondence.