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FDA 510(k)

Sonomed IV, Sonomed V

K-Number: K202788 · 2021-12-23

ApplicantCarci Industria E Comercio DE Aparelhos Cirurgicos E Orto
Decision Date2021-12-23
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Sonomed IV, Sonomed V is the device name listed in this FDA 510(k) record. The listed applicant is Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto. It received FDA 510(k) clearance on 2021-12-23 under 510(k) number K202788. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sonomed IV, Sonomed V?

Sonomed IV, Sonomed V is a medical device that received FDA 510(k) clearance on 2021-12-23. The listed applicant is Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto. The 510(k) number is K202788.

When did Sonomed IV, Sonomed V receive FDA 510(k) clearance?

Sonomed IV, Sonomed V received FDA 510(k) clearance on 2021-12-23, under 510(k) number K202788.

Who is the listed applicant for Sonomed IV, Sonomed V?

The FDA 510(k) record lists Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sonomed IV, Sonomed V?

The FDA product code for Sonomed IV, Sonomed V is IMI.

Related Devices (Code: IMI)

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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