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FDA 510(k)

CUFFALERT

K-Number: K081805 · 2008-11-14

ApplicantSunmed
Decision Date2008-11-14
Product CodeBSK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CUFFALERT is the device name listed in this FDA 510(k) record. The listed applicant is Sunmed. It received FDA 510(k) clearance on 2008-11-14 under 510(k) number K081805. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUFFALERT?

CUFFALERT is a medical device that received FDA 510(k) clearance on 2008-11-14. The listed applicant is Sunmed. The 510(k) number is K081805.

When did CUFFALERT receive FDA 510(k) clearance?

CUFFALERT received FDA 510(k) clearance on 2008-11-14, under 510(k) number K081805.

Who is the listed applicant for CUFFALERT?

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

What is the FDA product code for CUFFALERT?

The FDA product code for CUFFALERT is BSK.

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Related Devices (Code: BSK)

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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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