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FDA 510(k)

RESTROSPECTIVE ECG MEMORY MODULE

K-Number: K831406 · 1983-07-07

ApplicantCardiac Evaluation Center, Inc.
Decision Date1983-07-07
Product Code
DecisionSubstantially Equivalent

Device Summary

RESTROSPECTIVE ECG MEMORY MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Evaluation Center, Inc.. It received FDA 510(k) clearance on 1983-07-07 under 510(k) number K831406. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESTROSPECTIVE ECG MEMORY MODULE?

RESTROSPECTIVE ECG MEMORY MODULE is a medical device that received FDA 510(k) clearance on 1983-07-07. The listed applicant is Cardiac Evaluation Center, Inc.. The 510(k) number is K831406.

When did RESTROSPECTIVE ECG MEMORY MODULE receive FDA 510(k) clearance?

RESTROSPECTIVE ECG MEMORY MODULE received FDA 510(k) clearance on 1983-07-07, under 510(k) number K831406.

Who is the listed applicant for RESTROSPECTIVE ECG MEMORY MODULE?

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

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 Cardiac Evaluation Center, 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.

K954163RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER

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.

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