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)

FULL-DISCLOSURE AMBULATORY ECG SYSTEM

K-Number: K823529 · 1982-12-15

ApplicantClinical Data, Inc.
Decision Date1982-12-15
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FULL-DISCLOSURE AMBULATORY ECG SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Data, Inc.. It received FDA 510(k) clearance on 1982-12-15 under 510(k) number K823529. 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 FULL-DISCLOSURE AMBULATORY ECG SYSTEM?

FULL-DISCLOSURE AMBULATORY ECG SYSTEM is a medical device that received FDA 510(k) clearance on 1982-12-15. The listed applicant is Clinical Data, Inc.. The 510(k) number is K823529.

When did FULL-DISCLOSURE AMBULATORY ECG SYSTEM receive FDA 510(k) clearance?

FULL-DISCLOSURE AMBULATORY ECG SYSTEM received FDA 510(k) clearance on 1982-12-15, under 510(k) number K823529.

Who is the listed applicant for FULL-DISCLOSURE AMBULATORY ECG SYSTEM?

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

What is the FDA product code for FULL-DISCLOSURE AMBULATORY ECG SYSTEM?

The FDA product code for FULL-DISCLOSURE AMBULATORY ECG SYSTEM 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 Clinical Data, 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.

K071706ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)K052591NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KITK033983VITALAB IRON REAGENTK040631VITALAB DIRECT BILIRUBIN REAGENTK040534VITALAB AMYLASE REAGENTK034000VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR

View all 36 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.

↑