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FDA 510(k)

NORAV HOLTER SYSTEM, MODEL NH-300 V1.07

K-Number: K012712 · 2002-05-08

ApplicantNorav Medical , Ltd.
Decision Date2002-05-08
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 is the device name listed in this FDA 510(k) record. The listed applicant is Norav Medical , Ltd.. It received FDA 510(k) clearance on 2002-05-08 under 510(k) number K012712. 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 NORAV HOLTER SYSTEM, MODEL NH-300 V1.07?

NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 is a medical device that received FDA 510(k) clearance on 2002-05-08. The listed applicant is Norav Medical , Ltd.. The 510(k) number is K012712.

When did NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 receive FDA 510(k) clearance?

NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 received FDA 510(k) clearance on 2002-05-08, under 510(k) number K012712.

Who is the listed applicant for NORAV HOLTER SYSTEM, MODEL NH-300 V1.07?

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

What is the FDA product code for NORAV HOLTER SYSTEM, MODEL NH-300 V1.07?

The FDA product code for NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 is MLO.

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Related Devices (Code: 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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