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FDA 510(k)

Icare ic100

K-Number: K153694 · 2016-04-19

Decision Date2016-04-19
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Icare ic100 is the device name listed in this FDA 510(k) record. The listed applicant is Icare Finland OY. It received FDA 510(k) clearance on 2016-04-19 under 510(k) number K153694. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Icare ic100?

Icare ic100 is a medical device that received FDA 510(k) clearance on 2016-04-19. The listed applicant is Icare Finland OY. The 510(k) number is K153694.

When did Icare ic100 receive FDA 510(k) clearance?

Icare ic100 received FDA 510(k) clearance on 2016-04-19, under 510(k) number K153694.

Who is the listed applicant for Icare ic100?

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

What is the FDA product code for Icare ic100?

The FDA product code for Icare ic100 is HKY.

Related Clinical Trials

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.

Other records listing Icare Finland OY 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 7 devices →

Related Devices (Code: HKY)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.