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FDA 510(k)

ACTICARE IC AND TSE

K-Number: K081835 · 2009-03-19

ApplicantBioinduction Limited
Decision Date2009-03-19
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACTICARE IC AND TSE is the device name listed in this FDA 510(k) record. The listed applicant is Bioinduction Limited. It received FDA 510(k) clearance on 2009-03-19 under 510(k) number K081835. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTICARE IC AND TSE?

ACTICARE IC AND TSE is a medical device that received FDA 510(k) clearance on 2009-03-19. The listed applicant is Bioinduction Limited. The 510(k) number is K081835.

When did ACTICARE IC AND TSE receive FDA 510(k) clearance?

ACTICARE IC AND TSE received FDA 510(k) clearance on 2009-03-19, under 510(k) number K081835.

Who is the listed applicant for ACTICARE IC AND TSE?

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

What is the FDA product code for ACTICARE IC AND TSE?

The FDA product code for ACTICARE IC AND TSE is GZJ.

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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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