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FDA 510(k)

SOMNITOR 32K SLEEP ACTIVITY MONITOR

K-Number: K965079 · 1997-07-10

ApplicantNeurim Pharmaceuticals, Ltd.
Decision Date1997-07-10
Product CodeLEL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SOMNITOR 32K SLEEP ACTIVITY MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Neurim Pharmaceuticals, Ltd.. It received FDA 510(k) clearance on 1997-07-10 under 510(k) number K965079. The device is classified under product code LEL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOMNITOR 32K SLEEP ACTIVITY MONITOR?

SOMNITOR 32K SLEEP ACTIVITY MONITOR is a medical device that received FDA 510(k) clearance on 1997-07-10. The listed applicant is Neurim Pharmaceuticals, Ltd.. The 510(k) number is K965079.

When did SOMNITOR 32K SLEEP ACTIVITY MONITOR receive FDA 510(k) clearance?

SOMNITOR 32K SLEEP ACTIVITY MONITOR received FDA 510(k) clearance on 1997-07-10, under 510(k) number K965079.

Who is the listed applicant for SOMNITOR 32K SLEEP ACTIVITY MONITOR?

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

What is the FDA product code for SOMNITOR 32K SLEEP ACTIVITY MONITOR?

The FDA product code for SOMNITOR 32K SLEEP ACTIVITY MONITOR is LEL.

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Related Devices (Code: LEL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252981EmbraceMiniEmpatica S.r.l.K251574Sleep WatchAmbulatory Monitoring, Inc.K243513DCM (PW-DCM)Pneumowave, Ltd.K233987VERABAND™Arbor Medical Innovations, LLCK233618Oxevision Sleep DeviceOxehealth LimitedK231532ActiGraph LEAP activity monitor (ActiGraph LEAP)Actigraph, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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