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FDA 510(k)

SOMNIMIC (R)

K-Number: K912817 · 1991-07-26

ApplicantSomnitec, Inc.
Decision Date1991-07-26
Product CodeLEL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SOMNIMIC (R) is the device name listed in this FDA 510(k) record. The listed applicant is Somnitec, Inc.. It received FDA 510(k) clearance on 1991-07-26 under 510(k) number K912817. 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 SOMNIMIC (R)?

SOMNIMIC (R) is a medical device that received FDA 510(k) clearance on 1991-07-26. The listed applicant is Somnitec, Inc.. The 510(k) number is K912817.

When did SOMNIMIC (R) receive FDA 510(k) clearance?

SOMNIMIC (R) received FDA 510(k) clearance on 1991-07-26, under 510(k) number K912817.

Who is the listed applicant for SOMNIMIC (R)?

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

What is the FDA product code for SOMNIMIC (R)?

The FDA product code for SOMNIMIC (R) is LEL.

Related Clinical Trials

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.

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Other records listing Somnitec, Inc. as applicant

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.

K911989GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT.K912234SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATIONK911990ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT.

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

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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