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FDA 510(k)

EMT-102 CARDIAC MONITOR

K-Number: K870049 · 1987-04-22

ApplicantEvergreen Medical Technologies, Inc.
Decision Date1987-04-22
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMT-102 CARDIAC MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Evergreen Medical Technologies, Inc.. It received FDA 510(k) clearance on 1987-04-22 under 510(k) number K870049. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMT-102 CARDIAC MONITOR?

EMT-102 CARDIAC MONITOR is a medical device that received FDA 510(k) clearance on 1987-04-22. The listed applicant is Evergreen Medical Technologies, Inc.. The 510(k) number is K870049.

When did EMT-102 CARDIAC MONITOR receive FDA 510(k) clearance?

EMT-102 CARDIAC MONITOR received FDA 510(k) clearance on 1987-04-22, under 510(k) number K870049.

Who is the listed applicant for EMT-102 CARDIAC MONITOR?

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

What is the FDA product code for EMT-102 CARDIAC MONITOR?

The FDA product code for EMT-102 CARDIAC MONITOR is DXN.

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Related Devices (Code: DXN)

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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