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FDA 510(k)

HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM

K-Number: K073269 · 2008-04-18

ApplicantHypnocore, Ltd.
Decision Date2008-04-18
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hypnocore, Ltd.. It received FDA 510(k) clearance on 2008-04-18 under 510(k) number K073269. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM?

HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-18. The listed applicant is Hypnocore, Ltd.. The 510(k) number is K073269.

When did HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM receive FDA 510(k) clearance?

HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM received FDA 510(k) clearance on 2008-04-18, under 510(k) number K073269.

Who is the listed applicant for HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM?

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

What is the FDA product code for HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM?

The FDA product code for HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM is MNR.

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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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