Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RemLogic

K-Number: K162140 · 2016-12-01

ApplicantEmbla Systems
Decision Date2016-12-01
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RemLogic is the device name listed in this FDA 510(k) record. The listed applicant is Embla Systems. It received FDA 510(k) clearance on 2016-12-01 under 510(k) number K162140. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RemLogic?

RemLogic is a medical device that received FDA 510(k) clearance on 2016-12-01. The listed applicant is Embla Systems. The 510(k) number is K162140.

When did RemLogic receive FDA 510(k) clearance?

RemLogic received FDA 510(k) clearance on 2016-12-01, under 510(k) number K162140.

Who is the listed applicant for RemLogic?

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

What is the FDA product code for RemLogic?

The FDA product code for RemLogic is OLZ.

Other records listing Embla Systems 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.

K180001Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor InfantK173793XactTrace Single Use Respiratory Effort Belt SystemK172703Disposable Snap ElectrodeK163617REMbrandtK153353SANDMAN ELITE

Related Devices (Code: OLZ)

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.

K253390SOMNUM (SOMNUM)Honeynaps Co., Ltd.K253668Onera SleepMap (SLEEPMAP)Onera B.V.K250851Hypnos (369054-200)Cadwell Industries, Inc.K252330DeepRESPNox Medical EhfK250058NEAT 001Brain Electrophysiology Laboratory Company, LLCK241960DeepRESPNox Medical Ehf

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.

↑