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FDA 510(k)

HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010

K-Number: K152029 · 2016-05-03

ApplicantHamilton Medical AG
Decision Date2016-05-03
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 is a medical device manufactured by Hamilton Medical AG. It received FDA 510(k) clearance on 2016-05-03 under approval number K152029. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010?

HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 is a medical device that received FDA 510(k) clearance on 2016-05-03. It is manufactured by Hamilton Medical AG. The 510(k) number is K152029.

When was HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 approved by the FDA?

HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 received FDA 510(k) clearance on 2016-05-03, under approval number K152029.

What company makes HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010?

HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 is manufactured by Hamilton Medical AG.

What is the FDA product code for HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010?

The FDA product code for HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 is BTT.

Other Devices by Hamilton Medical AG

K153046HAMILTON-MR1 K150893IntelliCuff K163283HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 K161450HAMILTON-C3 K181216HAMILTON-T1, HAMILTON-C1 K201658Hamilton-C6

View all 9 devices →

Related Devices (Code: BTT)

K160764AirLife Autofill Humidification ChamberCarefusion 2200, Inc. K161314FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASEFlexicare Medical Limited. K161719Salter Labs Bubble HumidifierSalter Labs K163283HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010Hamilton Medical AG K162242Comfort Flo Humidification SystemTeleflexmedical, Inc. K162553AirSpiral Heated Breathing TubeFisher & Paykel Healthcare

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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