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FDA 510(k)

NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800

K-Number: K092699 · 2010-03-18

ApplicantNeurotronics, Inc.
Decision Date2010-03-18
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 is the device name listed in this FDA 510(k) record. The listed applicant is Neurotronics, Inc.. It received FDA 510(k) clearance on 2010-03-18 under 510(k) number K092699. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800?

NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 is a medical device that received FDA 510(k) clearance on 2010-03-18. The listed applicant is Neurotronics, Inc.. The 510(k) number is K092699.

When did NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 receive FDA 510(k) clearance?

NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 received FDA 510(k) clearance on 2010-03-18, under 510(k) number K092699.

Who is the listed applicant for NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800?

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

What is the FDA product code for NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800?

The FDA product code for NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 is GWL.

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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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