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FDA 510(k)

SONOWAND INVITE

K-Number: K083597 · 2009-09-25

ApplicantSonowand AS
Decision Date2009-09-25
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SONOWAND INVITE is the device name listed in this FDA 510(k) record. The listed applicant is Sonowand AS. It received FDA 510(k) clearance on 2009-09-25 under 510(k) number K083597. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOWAND INVITE?

SONOWAND INVITE is a medical device that received FDA 510(k) clearance on 2009-09-25. The listed applicant is Sonowand AS. The 510(k) number is K083597.

When did SONOWAND INVITE receive FDA 510(k) clearance?

SONOWAND INVITE received FDA 510(k) clearance on 2009-09-25, under 510(k) number K083597.

Who is the listed applicant for SONOWAND INVITE?

The FDA 510(k) record lists Sonowand AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONOWAND INVITE?

The FDA product code for SONOWAND INVITE is HAW.

Related Clinical Trials

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Other records listing Sonowand AS 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.

K112469GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM

Related Devices (Code: HAW)

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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