Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TEC-3500 DEFIBRILLATOR

K-Number: K840258 · 1984-05-23

ApplicantNihon Kohden America, Inc.
Decision Date1984-05-23
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TEC-3500 DEFIBRILLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 1984-05-23 under 510(k) number K840258. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEC-3500 DEFIBRILLATOR?

TEC-3500 DEFIBRILLATOR is a medical device that received FDA 510(k) clearance on 1984-05-23. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K840258.

When did TEC-3500 DEFIBRILLATOR receive FDA 510(k) clearance?

TEC-3500 DEFIBRILLATOR received FDA 510(k) clearance on 1984-05-23, under 510(k) number K840258.

Who is the listed applicant for TEC-3500 DEFIBRILLATOR?

The FDA 510(k) record lists Nihon Kohden America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEC-3500 DEFIBRILLATOR?

The FDA product code for TEC-3500 DEFIBRILLATOR is LDD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Nihon Kohden America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K113117NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOXK120485NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT PK092573NIHON KOHDEN QP-160AK EEG TREND PROGRAMK083456NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970PK083271BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORYK082785NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES

View all 166 devices →

Related Devices (Code: LDD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203231Switched Internal PaddlesPhilips North America, LLCK200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips CompanyK182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc.K103651CARDIOMEDCardio Medical Products, Inc.K103783EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRICFiab SpaK103334CARDIO MEDCardio Medical Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑