FDA 510(k)

BARD NEONATAL ECG MONITORING ELECTRODE

K-Number: K891075 · 1989-03-22

Decision Date1989-03-22

Product CodeDRX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BARD NEONATAL ECG MONITORING ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 1989-03-22 under 510(k) number K891075. 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 BARD NEONATAL ECG MONITORING ELECTRODE?

BARD NEONATAL ECG MONITORING ELECTRODE is a medical device that received FDA 510(k) clearance on 1989-03-22. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K891075.

When did BARD NEONATAL ECG MONITORING ELECTRODE receive FDA 510(k) clearance?

BARD NEONATAL ECG MONITORING ELECTRODE received FDA 510(k) clearance on 1989-03-22, under 510(k) number K891075.

Who is the listed applicant for BARD NEONATAL ECG MONITORING ELECTRODE?

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

What is the FDA product code for BARD NEONATAL ECG MONITORING ELECTRODE?

The FDA product code for BARD NEONATAL ECG MONITORING ELECTRODE is DRX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.