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)

SLEEP STAGER

K-Number: K850541 · 1985-08-02

ApplicantOxford Medilog, Inc.
Decision Date1985-08-02
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SLEEP STAGER is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Medilog, Inc.. It received FDA 510(k) clearance on 1985-08-02 under 510(k) number K850541. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLEEP STAGER?

SLEEP STAGER is a medical device that received FDA 510(k) clearance on 1985-08-02. The listed applicant is Oxford Medilog, Inc.. The 510(k) number is K850541.

When did SLEEP STAGER receive FDA 510(k) clearance?

SLEEP STAGER received FDA 510(k) clearance on 1985-08-02, under 510(k) number K850541.

Who is the listed applicant for SLEEP STAGER?

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

What is the FDA product code for SLEEP STAGER?

The FDA product code for SLEEP STAGER is OLT.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Oxford Medilog, 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.

K923737MODEL MEDILOG RAPIDEK920295MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED)K912890MODEL SONICAID AXISK912639SONICAID TEAMK904763MENTOR EEG SYSTEMK902690SONICAID MODEL MERIDIAN 800

View all 48 devices →

Related Devices (Code: OLT)

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.

K261712Ceribell EEG Analysis SoftwareCeribell, Inc.K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.K253767UB ERP SystemUniversal BrainK251881HippoMind (v1.0)HippoclinicK251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)Nihon Kohden CorporationK240593VEEGix EEG SystemNeuroServo, Inc.

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.

↑