TENACORE LLC

FDA Device Registration & Listing · Costa Mesa, CA, US · Registration 3008403701

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
3008403701
FEI Number
3008403701
Entity Name
TENACORE LLC
City/State/Country
Costa Mesa, CA, US
Establishment Address
3115 Airway Ave, Costa Mesa, CA 92626, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Tenacore LLC (Owner Number: 10080555)
Owner / Operator Contact Address
3115 Airway Ave, Costa Mesa, CA 92626, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K043075
PMA Number
N/A

All Registered Proprietary Names

Tenacore Transducers For Fetal Ultrasonic And Tokodynamometer Monitoring

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 2021-02-09

Official Correspondent

Jason Craner

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tenacore LLC
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 3008403701. Last updated year: 2026. Please use registration number 3008403701 when referencing this establishment in official correspondence.
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