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FDA 510(k)

CARE3 PLUS

K-Number: K081811 · 2009-01-21

ApplicantNakanishi, Inc.
Decision Date2009-01-21
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CARE3 PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Nakanishi, Inc.. It received FDA 510(k) clearance on 2009-01-21 under 510(k) number K081811. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARE3 PLUS?

CARE3 PLUS is a medical device that received FDA 510(k) clearance on 2009-01-21. The listed applicant is Nakanishi, Inc.. The 510(k) number is K081811.

When did CARE3 PLUS receive FDA 510(k) clearance?

CARE3 PLUS received FDA 510(k) clearance on 2009-01-21, under 510(k) number K081811.

Who is the listed applicant for CARE3 PLUS?

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

What is the FDA product code for CARE3 PLUS?

The FDA product code for CARE3 PLUS is EFB.

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Official Source

View on FDA Database →

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

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