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FDA 510(k)

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010

K-Number: K163283 · 2017-09-20

ApplicantHamilton Medical AG
Decision Date2017-09-20
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 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 2017-09-20 under 510(k) number K163283. 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-BC8010, HAMILTON-BC4010?

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 is a medical device that received FDA 510(k) clearance on 2017-09-20. The listed applicant is Hamilton Medical AG. The 510(k) number is K163283.

When did HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 receive FDA 510(k) clearance?

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 received FDA 510(k) clearance on 2017-09-20, under 510(k) number K163283.

Who is the listed applicant for HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010?

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 HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010?

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

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-C3K201658Hamilton-C6K193228Hamilton-G5K181216HAMILTON-T1, HAMILTON-C1K161450HAMILTON-C3K153046HAMILTON-MR1

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Related Devices (Code: BTT)

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.

K254078HVT 2.0Vapotherm, Inc.K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallMedline Industries, LPK251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)Fisher & Paykel Healthcare, Ltd.

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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