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)

SLEEPSCAN

K-Number: K894155 · 1990-01-26

ApplicantBiologic Systems Corp.
Decision Date1990-01-26
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SLEEPSCAN is the device name listed in this FDA 510(k) record. The listed applicant is Biologic Systems Corp.. It received FDA 510(k) clearance on 1990-01-26 under 510(k) number K894155. 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 SLEEPSCAN?

SLEEPSCAN is a medical device that received FDA 510(k) clearance on 1990-01-26. The listed applicant is Biologic Systems Corp.. The 510(k) number is K894155.

When did SLEEPSCAN receive FDA 510(k) clearance?

SLEEPSCAN received FDA 510(k) clearance on 1990-01-26, under 510(k) number K894155.

Who is the listed applicant for SLEEPSCAN?

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

What is the FDA product code for SLEEPSCAN?

The FDA product code for SLEEPSCAN is OLZ.

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

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.

↑