FDA 510(k)

SYNCOR (R) MODEL S-801 ECG ELECTRODE

K-Number: K882216 · 1988-07-20

Decision Date1988-07-20

Product CodeDRX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SYNCOR (R) MODEL S-801 ECG ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Lectec Corp.. It received FDA 510(k) clearance on 1988-07-20 under 510(k) number K882216. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCOR (R) MODEL S-801 ECG ELECTRODE?

SYNCOR (R) MODEL S-801 ECG ELECTRODE is a medical device that received FDA 510(k) clearance on 1988-07-20. The listed applicant is Lectec Corp.. The 510(k) number is K882216.

When did SYNCOR (R) MODEL S-801 ECG ELECTRODE receive FDA 510(k) clearance?

SYNCOR (R) MODEL S-801 ECG ELECTRODE received FDA 510(k) clearance on 1988-07-20, under 510(k) number K882216.

Who is the listed applicant for SYNCOR (R) MODEL S-801 ECG ELECTRODE?

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

What is the FDA product code for SYNCOR (R) MODEL S-801 ECG ELECTRODE?

The FDA product code for SYNCOR (R) MODEL S-801 ECG ELECTRODE is DRX.

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Related Devices (Code: DRX)

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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.