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)

BIOSACA SYSTEM

K-Number: K984580 · 1999-03-12

ApplicantBiosys AB (Publ)
Decision Date1999-03-12
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIOSACA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biosys AB (Publ). It received FDA 510(k) clearance on 1999-03-12 under 510(k) number K984580. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSACA SYSTEM?

BIOSACA SYSTEM is a medical device that received FDA 510(k) clearance on 1999-03-12. The listed applicant is Biosys AB (Publ). The 510(k) number is K984580.

When did BIOSACA SYSTEM receive FDA 510(k) clearance?

BIOSACA SYSTEM received FDA 510(k) clearance on 1999-03-12, under 510(k) number K984580.

Who is the listed applicant for BIOSACA SYSTEM?

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

What is the FDA product code for BIOSACA SYSTEM?

The FDA product code for BIOSACA SYSTEM is OLV.

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 Biosys AB (Publ) 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.

K991446BIOSACA SYSTEM, MODEL 800

Related Devices (Code: OLV)

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.

K261747Report StudioBeacon Biosignals, Inc.K260585Noxturnal WebNox Medical EhfK242447Falcon HSTCompumedics LimitedK241288Noxturnal WebNox Medical EhfK240700HomeSleepTest (HST, HST REM+)Somnomedics GmbHK213007Cerebra Sleep SystemCerebra Medical , Ltd.

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.

↑