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)

ECG ARRHYTHMIA STIMULATOR

K-Number: K810104 · 1981-01-29

ApplicantBelmont Instrument Corp.
Decision Date1981-01-29
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG ARRHYTHMIA STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Belmont Instrument Corp.. It received FDA 510(k) clearance on 1981-01-29 under 510(k) number K810104. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECG ARRHYTHMIA STIMULATOR?

ECG ARRHYTHMIA STIMULATOR is a medical device that received FDA 510(k) clearance on 1981-01-29. The listed applicant is Belmont Instrument Corp.. The 510(k) number is K810104.

When did ECG ARRHYTHMIA STIMULATOR receive FDA 510(k) clearance?

ECG ARRHYTHMIA STIMULATOR received FDA 510(k) clearance on 1981-01-29, under 510(k) number K810104.

Who is the listed applicant for ECG ARRHYTHMIA STIMULATOR?

The FDA 510(k) record lists Belmont Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG ARRHYTHMIA STIMULATOR?

The FDA product code for ECG ARRHYTHMIA STIMULATOR is DPS.

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 Belmont Instrument Corp. 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.

K131519BELMONT HYPERTHERMIA PUMPK112639THE BELMONT BUDDY LITE FLUID WARMERK091855THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000K090508THE BELMONT BUDDY LITE FLUID WARMERK090089BELMONT HYPERTHERMIA PUMPK070654HYPERTHERMIA PUMP

View all 20 devices →

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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.

↑