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FDA 510(k)

RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER

K-Number: K954163 · 1996-07-11

ApplicantCardiac Evaluation Center, Inc.
Decision Date1996-07-11
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER 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 1996-07-11 under 510(k) number K954163. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER?

RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER is a medical device that received FDA 510(k) clearance on 1996-07-11. The listed applicant is Cardiac Evaluation Center, Inc.. The 510(k) number is K954163.

When did RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER receive FDA 510(k) clearance?

RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER received FDA 510(k) clearance on 1996-07-11, under 510(k) number K954163.

Who is the listed applicant for RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER?

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

What is the FDA product code for RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER?

The FDA product code for RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER is DXH. This falls under the Hematology category.

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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.

K831406RESTROSPECTIVE ECG MEMORY MODULE

Related Devices (Code: DXH)

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.

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Official Source

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

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