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FDA 510(k)

BIOSACA SYSTEM, MODEL 800

K-Number: K991446 · 1999-07-23

ApplicantBiosys AB (Publ)
Decision Date1999-07-23
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIOSACA SYSTEM, MODEL 800 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 1999-07-23 under 510(k) number K991446. 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, MODEL 800?

BIOSACA SYSTEM, MODEL 800 is a medical device that received FDA 510(k) clearance on 1999-07-23. The listed applicant is Biosys AB (Publ). The 510(k) number is K991446.

When did BIOSACA SYSTEM, MODEL 800 receive FDA 510(k) clearance?

BIOSACA SYSTEM, MODEL 800 received FDA 510(k) clearance on 1999-07-23, under 510(k) number K991446.

Who is the listed applicant for BIOSACA SYSTEM, MODEL 800?

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, MODEL 800?

The FDA product code for BIOSACA SYSTEM, MODEL 800 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.

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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.

K984580BIOSACA SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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