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FDA 510(k)

MODIFICATION TO BIO-LOGIC SLEEPSCAN

K-Number: K983913 · 1998-11-25

ApplicantBio-Logic Systems Corp.
Decision Date1998-11-25
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO BIO-LOGIC SLEEPSCAN is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Logic Systems Corp.. It received FDA 510(k) clearance on 1998-11-25 under 510(k) number K983913. 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 MODIFICATION TO BIO-LOGIC SLEEPSCAN?

MODIFICATION TO BIO-LOGIC SLEEPSCAN is a medical device that received FDA 510(k) clearance on 1998-11-25. The listed applicant is Bio-Logic Systems Corp.. The 510(k) number is K983913.

When did MODIFICATION TO BIO-LOGIC SLEEPSCAN receive FDA 510(k) clearance?

MODIFICATION TO BIO-LOGIC SLEEPSCAN received FDA 510(k) clearance on 1998-11-25, under 510(k) number K983913.

Who is the listed applicant for MODIFICATION TO BIO-LOGIC SLEEPSCAN?

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

What is the FDA product code for MODIFICATION TO BIO-LOGIC SLEEPSCAN?

The FDA product code for MODIFICATION TO BIO-LOGIC SLEEPSCAN is OLV.

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Other records listing Bio-Logic Systems Corp. as applicant

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Related Devices (Code: OLV)

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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.

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