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FDA 510(k)

CYGNUS 12 LEAD ECG MODULE

K-Number: K072950 · 2008-08-22

ApplicantCygnus, LLC
Decision Date2008-08-22
Product CodeKRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CYGNUS 12 LEAD ECG MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Cygnus, LLC. It received FDA 510(k) clearance on 2008-08-22 under 510(k) number K072950. The device is classified under product code KRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYGNUS 12 LEAD ECG MODULE?

CYGNUS 12 LEAD ECG MODULE is a medical device that received FDA 510(k) clearance on 2008-08-22. The listed applicant is Cygnus, LLC. The 510(k) number is K072950.

When did CYGNUS 12 LEAD ECG MODULE receive FDA 510(k) clearance?

CYGNUS 12 LEAD ECG MODULE received FDA 510(k) clearance on 2008-08-22, under 510(k) number K072950.

Who is the listed applicant for CYGNUS 12 LEAD ECG MODULE?

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

What is the FDA product code for CYGNUS 12 LEAD ECG MODULE?

The FDA product code for CYGNUS 12 LEAD ECG MODULE is KRE.

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Related Devices (Code: KRE)

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

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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