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FDA 510(k)

SONARA; SONARA/TEK

K-Number: K060421 · 2006-11-03

ApplicantViasys Healthcare, Inc.
Decision Date2006-11-03
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONARA; SONARA/TEK is the device name listed in this FDA 510(k) record. The listed applicant is Viasys Healthcare, Inc.. It received FDA 510(k) clearance on 2006-11-03 under 510(k) number K060421. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONARA; SONARA/TEK?

SONARA; SONARA/TEK is a medical device that received FDA 510(k) clearance on 2006-11-03. The listed applicant is Viasys Healthcare, Inc.. The 510(k) number is K060421.

When did SONARA; SONARA/TEK receive FDA 510(k) clearance?

SONARA; SONARA/TEK received FDA 510(k) clearance on 2006-11-03, under 510(k) number K060421.

Who is the listed applicant for SONARA; SONARA/TEK?

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

What is the FDA product code for SONARA; SONARA/TEK?

The FDA product code for SONARA; SONARA/TEK is IYN.

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Other records listing Viasys Healthcare, Inc. as applicant

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Related Devices (Code: IYN)

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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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