FDA 510(k)

EXERCISE ECG ELECTRODES, REUSABLE

K-Number: K821384 · 1982-06-17

Decision Date1982-06-17

Product CodeDRG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EXERCISE ECG ELECTRODES, REUSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 1982-06-17 under 510(k) number K821384. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXERCISE ECG ELECTRODES, REUSABLE?

EXERCISE ECG ELECTRODES, REUSABLE is a medical device that received FDA 510(k) clearance on 1982-06-17. The listed applicant is Respironics, Inc.. The 510(k) number is K821384.

When did EXERCISE ECG ELECTRODES, REUSABLE receive FDA 510(k) clearance?

EXERCISE ECG ELECTRODES, REUSABLE received FDA 510(k) clearance on 1982-06-17, under 510(k) number K821384.

Who is the listed applicant for EXERCISE ECG ELECTRODES, REUSABLE?

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

What is the FDA product code for EXERCISE ECG ELECTRODES, REUSABLE?

The FDA product code for EXERCISE ECG ELECTRODES, REUSABLE is DRG.

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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.