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FDA 510(k)

BIOLOGIC SYSTEM BL 101

K-Number: K831047 · 1983-05-13

ApplicantBio-Logic Systems Corp.
Decision Date1983-05-13
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIOLOGIC SYSTEM BL 101 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 1983-05-13 under 510(k) number K831047. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOLOGIC SYSTEM BL 101?

BIOLOGIC SYSTEM BL 101 is a medical device that received FDA 510(k) clearance on 1983-05-13. The listed applicant is Bio-Logic Systems Corp.. The 510(k) number is K831047.

When did BIOLOGIC SYSTEM BL 101 receive FDA 510(k) clearance?

BIOLOGIC SYSTEM BL 101 received FDA 510(k) clearance on 1983-05-13, under 510(k) number K831047.

Who is the listed applicant for BIOLOGIC SYSTEM BL 101?

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 BIOLOGIC SYSTEM BL 101?

The FDA product code for BIOLOGIC SYSTEM BL 101 is GWE.

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Other records listing Bio-Logic Systems Corp. 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.

K122496AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEMK121512SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEMK073626BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEMK061744COCHLEA-SCAN / COCHLEA-SCAN PLUSK052066CEEGRAPH/SLEEPSCAN NETLINK TRAVELERK031352BIO-LOGIC INSERT EARPHONES

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Related Devices (Code: GWE)

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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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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