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FDA 510(k)

Piezon Built-in Kit, Piezon Built-in Kit LED

K-Number: K191079 · 2019-08-16

Decision Date2019-08-16
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Piezon Built-in Kit, Piezon Built-in Kit LED is the device name listed in this FDA 510(k) record. The listed applicant is E.M.S Electro Medical Systems S.A. It received FDA 510(k) clearance on 2019-08-16 under 510(k) number K191079. 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 Piezon Built-in Kit, Piezon Built-in Kit LED?

Piezon Built-in Kit, Piezon Built-in Kit LED is a medical device that received FDA 510(k) clearance on 2019-08-16. The listed applicant is E.M.S Electro Medical Systems S.A. The 510(k) number is K191079.

When did Piezon Built-in Kit, Piezon Built-in Kit LED receive FDA 510(k) clearance?

Piezon Built-in Kit, Piezon Built-in Kit LED received FDA 510(k) clearance on 2019-08-16, under 510(k) number K191079.

Who is the listed applicant for Piezon Built-in Kit, Piezon Built-in Kit LED?

The FDA 510(k) record lists E.M.S Electro Medical Systems S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Piezon Built-in Kit, Piezon Built-in Kit LED?

The FDA product code for Piezon Built-in Kit, Piezon Built-in Kit LED is ELC.

Other records listing E.M.S Electro Medical Systems S.A 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.

View all 14 devices →

Related Devices (Code: ELC)

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.

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.