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FDA 510(k)

NH-301 AMBULATORY ECG ANALYSIS SOFTWARE

K-Number: K111487 · 2011-11-10

ApplicantNorav Medical Corp.
Decision Date2011-11-10
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NH-301 AMBULATORY ECG ANALYSIS SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Norav Medical Corp.. It received FDA 510(k) clearance on 2011-11-10 under 510(k) number K111487. The device is classified under product code MLO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NH-301 AMBULATORY ECG ANALYSIS SOFTWARE?

NH-301 AMBULATORY ECG ANALYSIS SOFTWARE is a medical device that received FDA 510(k) clearance on 2011-11-10. The listed applicant is Norav Medical Corp.. The 510(k) number is K111487.

When did NH-301 AMBULATORY ECG ANALYSIS SOFTWARE receive FDA 510(k) clearance?

NH-301 AMBULATORY ECG ANALYSIS SOFTWARE received FDA 510(k) clearance on 2011-11-10, under 510(k) number K111487.

Who is the listed applicant for NH-301 AMBULATORY ECG ANALYSIS SOFTWARE?

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

What is the FDA product code for NH-301 AMBULATORY ECG ANALYSIS SOFTWARE?

The FDA product code for NH-301 AMBULATORY ECG ANALYSIS SOFTWARE is MLO.

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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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