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)

DIRECT WRITING VECTORCARDIOGRAPH

K-Number: K810529 · 1981-04-23

ApplicantElmed, Inc.
Decision Date1981-04-23
Product CodeDYC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIRECT WRITING VECTORCARDIOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Elmed, Inc.. It received FDA 510(k) clearance on 1981-04-23 under 510(k) number K810529. The device is classified under product code DYC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIRECT WRITING VECTORCARDIOGRAPH?

DIRECT WRITING VECTORCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1981-04-23. The listed applicant is Elmed, Inc.. The 510(k) number is K810529.

When did DIRECT WRITING VECTORCARDIOGRAPH receive FDA 510(k) clearance?

DIRECT WRITING VECTORCARDIOGRAPH received FDA 510(k) clearance on 1981-04-23, under 510(k) number K810529.

Who is the listed applicant for DIRECT WRITING VECTORCARDIOGRAPH?

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

What is the FDA product code for DIRECT WRITING VECTORCARDIOGRAPH?

The FDA product code for DIRECT WRITING VECTORCARDIOGRAPH is DYC.

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 Elmed, 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.

K010465DENSTATK974793ELMED ESU 120 M/M DIGITALK953271ELMED RF-ALERTK952110ELMED THERMO-FLUXK926517ELMED LBC 50-PK932938ELMED ESU 300 M/M AND DIGITAL

View all 26 devices →

Related Devices (Code: DYC)

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.

K023414MIDA ALGORITHM REV. BOrtivus ABK896396MIDA SYSTEM, MODELS 1000/1100Medical Graphics Corp.K823934CARIEL F12Odam

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.

↑