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FDA 510(k)

PIEZO TRONIC

K-Number: K982793 · 1998-10-28

ApplicantAdvanced Medical Devices, Inc.
Decision Date1998-10-28
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PIEZO TRONIC is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Devices, Inc.. It received FDA 510(k) clearance on 1998-10-28 under 510(k) number K982793. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIEZO TRONIC?

PIEZO TRONIC is a medical device that received FDA 510(k) clearance on 1998-10-28. The listed applicant is Advanced Medical Devices, Inc.. The 510(k) number is K982793.

When did PIEZO TRONIC receive FDA 510(k) clearance?

PIEZO TRONIC received FDA 510(k) clearance on 1998-10-28, under 510(k) number K982793.

Who is the listed applicant for PIEZO TRONIC?

The FDA 510(k) record lists Advanced Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIEZO TRONIC?

The FDA product code for PIEZO TRONIC is ELC.

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Other records listing Advanced Medical Devices, Inc. as applicant

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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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