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FDA 510(k)

Phoenix Clinical ICON

K-Number: K170527 · 2017-09-15

ApplicantPhoenix Technology Group, Inc. Dba Phoenix Clinical
Decision Date2017-09-15
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Phoenix Clinical ICON is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Technology Group, Inc. Dba Phoenix Clinical. It received FDA 510(k) clearance on 2017-09-15 under 510(k) number K170527. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Phoenix Clinical ICON?

Phoenix Clinical ICON is a medical device that received FDA 510(k) clearance on 2017-09-15. The listed applicant is Phoenix Technology Group, Inc. Dba Phoenix Clinical. The 510(k) number is K170527.

When did Phoenix Clinical ICON receive FDA 510(k) clearance?

Phoenix Clinical ICON received FDA 510(k) clearance on 2017-09-15, under 510(k) number K170527.

Who is the listed applicant for Phoenix Clinical ICON?

The FDA 510(k) record lists Phoenix Technology Group, Inc. Dba Phoenix Clinical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Phoenix Clinical ICON?

The FDA product code for Phoenix Clinical ICON is HKI.

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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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