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FDA 510(k)

FLEX-E1 ECG ELECTRODE

K-Number: K820579 · 1982-04-14

ApplicantConmedcorp
Decision Date1982-04-14
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLEX-E1 ECG ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Conmedcorp. It received FDA 510(k) clearance on 1982-04-14 under 510(k) number K820579. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEX-E1 ECG ELECTRODE?

FLEX-E1 ECG ELECTRODE is a medical device that received FDA 510(k) clearance on 1982-04-14. The listed applicant is Conmedcorp. The 510(k) number is K820579.

When did FLEX-E1 ECG ELECTRODE receive FDA 510(k) clearance?

FLEX-E1 ECG ELECTRODE received FDA 510(k) clearance on 1982-04-14, under 510(k) number K820579.

Who is the listed applicant for FLEX-E1 ECG ELECTRODE?

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

What is the FDA product code for FLEX-E1 ECG ELECTRODE?

The FDA product code for FLEX-E1 ECG ELECTRODE is DRS.

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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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