FDA 510(k)

IntelliCuff

K-Number: K150893 · 2016-01-29

Decision Date2016-01-29

Product CodeBSK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

IntelliCuff is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Medical AG. It received FDA 510(k) clearance on 2016-01-29 under 510(k) number K150893. 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 IntelliCuff?

IntelliCuff is a medical device that received FDA 510(k) clearance on 2016-01-29. The listed applicant is Hamilton Medical AG. The 510(k) number is K150893.

When did IntelliCuff receive FDA 510(k) clearance?

IntelliCuff received FDA 510(k) clearance on 2016-01-29, under 510(k) number K150893.

Who is the listed applicant for IntelliCuff?

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

What is the FDA product code for IntelliCuff?

The FDA product code for IntelliCuff is BSK.

Other records listing Hamilton Medical AG 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.

K201306HAMILTON-C3 K201658Hamilton-C6 K193228Hamilton-G5 K181216HAMILTON-T1, HAMILTON-C1 K163283HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 K161450HAMILTON-C3

View all 9 devices →

Related Devices (Code: BSK)

K261499TrachFlushAw Technologies Aps K243562CuffGuardIdmed K242642CuffTrekShanghai Longmann Tech Co., Ltd.K220854TrachCuff Cuff ControllerAw Technologies Aps K221477AG100sHospitech Respiration , Ltd.K202874Puritan Bennett Cuff Pressure ManagerCovidien, LLC

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.