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FDA 510(k)

ARRYTHMIA PRINTER OPTION

K-Number: K811792 · 1981-07-10

ApplicantAmerican Edwards Laboratories
Decision Date1981-07-10
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARRYTHMIA PRINTER OPTION is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811792. 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 ARRYTHMIA PRINTER OPTION?

ARRYTHMIA PRINTER OPTION is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is American Edwards Laboratories. The 510(k) number is K811792.

When did ARRYTHMIA PRINTER OPTION receive FDA 510(k) clearance?

ARRYTHMIA PRINTER OPTION received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811792.

Who is the listed applicant for ARRYTHMIA PRINTER OPTION?

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

What is the FDA product code for ARRYTHMIA PRINTER OPTION?

The FDA product code for ARRYTHMIA PRINTER OPTION is 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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