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FDA 510(k)

BIO-LOGIC INSERT EARPHONES

K-Number: K031352 · 2003-07-16

ApplicantBio-Logic Systems Corp.
Decision Date2003-07-16
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BIO-LOGIC INSERT EARPHONES 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 2003-07-16 under 510(k) number K031352. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-LOGIC INSERT EARPHONES?

BIO-LOGIC INSERT EARPHONES is a medical device that received FDA 510(k) clearance on 2003-07-16. The listed applicant is Bio-Logic Systems Corp.. The 510(k) number is K031352.

When did BIO-LOGIC INSERT EARPHONES receive FDA 510(k) clearance?

BIO-LOGIC INSERT EARPHONES received FDA 510(k) clearance on 2003-07-16, under 510(k) number K031352.

Who is the listed applicant for BIO-LOGIC INSERT EARPHONES?

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 BIO-LOGIC INSERT EARPHONES?

The FDA product code for BIO-LOGIC INSERT EARPHONES is EWO.

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Related Devices (Code: EWO)

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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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