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FDA 510(k)

EAR MUFFINS

K-Number: K012384 · 2001-10-15

ApplicantBio-Logic Systems Corp.
Decision Date2001-10-15
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EAR MUFFINS 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 2001-10-15 under 510(k) number K012384. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EAR MUFFINS?

EAR MUFFINS is a medical device that received FDA 510(k) clearance on 2001-10-15. The listed applicant is Bio-Logic Systems Corp.. The 510(k) number is K012384.

When did EAR MUFFINS receive FDA 510(k) clearance?

EAR MUFFINS received FDA 510(k) clearance on 2001-10-15, under 510(k) number K012384.

Who is the listed applicant for EAR MUFFINS?

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 EAR MUFFINS?

The FDA product code for EAR MUFFINS is HCC.

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Other records listing Bio-Logic Systems Corp. as applicant

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Related Devices (Code: HCC)

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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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