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FDA 510(k)

ARRHYTHMIA TREND ENHANCEMENT

K-Number: K780343 · 1978-04-18

ApplicantAmerican Optical Corp.
Decision Date1978-04-18
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARRHYTHMIA TREND ENHANCEMENT is the device name listed in this FDA 510(k) record. The listed applicant is American Optical Corp.. It received FDA 510(k) clearance on 1978-04-18 under 510(k) number K780343. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARRHYTHMIA TREND ENHANCEMENT?

ARRHYTHMIA TREND ENHANCEMENT is a medical device that received FDA 510(k) clearance on 1978-04-18. The listed applicant is American Optical Corp.. The 510(k) number is K780343.

When did ARRHYTHMIA TREND ENHANCEMENT receive FDA 510(k) clearance?

ARRHYTHMIA TREND ENHANCEMENT received FDA 510(k) clearance on 1978-04-18, under 510(k) number K780343.

Who is the listed applicant for ARRHYTHMIA TREND ENHANCEMENT?

The FDA 510(k) record lists American Optical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARRHYTHMIA TREND ENHANCEMENT?

The FDA product code for ARRHYTHMIA TREND ENHANCEMENT is DSI.

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Related Devices (Code: DSI)

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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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