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FDA 510(k)

ELECTROCARDIOGRAPH CONTINUOUS MONITOR

K-Number: K860457 · 1986-04-30

ApplicantOxford Medilog, Inc.
Decision Date1986-04-30
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELECTROCARDIOGRAPH CONTINUOUS MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Medilog, Inc.. It received FDA 510(k) clearance on 1986-04-30 under 510(k) number K860457. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROCARDIOGRAPH CONTINUOUS MONITOR?

ELECTROCARDIOGRAPH CONTINUOUS MONITOR is a medical device that received FDA 510(k) clearance on 1986-04-30. The listed applicant is Oxford Medilog, Inc.. The 510(k) number is K860457.

When did ELECTROCARDIOGRAPH CONTINUOUS MONITOR receive FDA 510(k) clearance?

ELECTROCARDIOGRAPH CONTINUOUS MONITOR received FDA 510(k) clearance on 1986-04-30, under 510(k) number K860457.

Who is the listed applicant for ELECTROCARDIOGRAPH CONTINUOUS MONITOR?

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

What is the FDA product code for ELECTROCARDIOGRAPH CONTINUOUS MONITOR?

The FDA product code for ELECTROCARDIOGRAPH CONTINUOUS MONITOR is GWN.

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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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