FDA 510(k)

NOAH MONITORING ELECTRODE SYSTEM

K-Number: K970125 · 1997-03-04

ApplicantContour Medical Technology, Inc.

Decision Date1997-03-04

Product CodeDRX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NOAH MONITORING ELECTRODE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Contour Medical Technology, Inc.. It received FDA 510(k) clearance on 1997-03-04 under 510(k) number K970125. 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 NOAH MONITORING ELECTRODE SYSTEM?

NOAH MONITORING ELECTRODE SYSTEM is a medical device that received FDA 510(k) clearance on 1997-03-04. The listed applicant is Contour Medical Technology, Inc.. The 510(k) number is K970125.

When did NOAH MONITORING ELECTRODE SYSTEM receive FDA 510(k) clearance?

NOAH MONITORING ELECTRODE SYSTEM received FDA 510(k) clearance on 1997-03-04, under 510(k) number K970125.

Who is the listed applicant for NOAH MONITORING ELECTRODE SYSTEM?

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

What is the FDA product code for NOAH MONITORING ELECTRODE SYSTEM?

The FDA product code for NOAH MONITORING ELECTRODE SYSTEM is DRX.

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Other records listing Contour Medical Technology, Inc. as applicant

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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.