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FDA 510(k)

BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS

K-Number: K021801 · 2002-06-27

ApplicantBio-Logic Systems Corp.
Decision Date2002-06-27
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS 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 2002-06-27 under 510(k) number K021801. 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 ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS?

BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS is a medical device that received FDA 510(k) clearance on 2002-06-27. The listed applicant is Bio-Logic Systems Corp.. The 510(k) number is K021801.

When did BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS receive FDA 510(k) clearance?

BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS received FDA 510(k) clearance on 2002-06-27, under 510(k) number K021801.

Who is the listed applicant for BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS?

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 ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS?

The FDA product code for BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS is EWO.

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Related Devices (Code: EWO)

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

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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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