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FDA 510(k)

MEDISIZE GOLD

K-Number: K052615 · 2005-12-09

ApplicantMedisize BV
Decision Date2005-12-09
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDISIZE GOLD is the device name listed in this FDA 510(k) record. The listed applicant is Medisize BV. It received FDA 510(k) clearance on 2005-12-09 under 510(k) number K052615. 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 MEDISIZE GOLD?

MEDISIZE GOLD is a medical device that received FDA 510(k) clearance on 2005-12-09. The listed applicant is Medisize BV. The 510(k) number is K052615.

When did MEDISIZE GOLD receive FDA 510(k) clearance?

MEDISIZE GOLD received FDA 510(k) clearance on 2005-12-09, under 510(k) number K052615.

Who is the listed applicant for MEDISIZE GOLD?

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

What is the FDA product code for MEDISIZE GOLD?

The FDA product code for MEDISIZE GOLD is BTT.

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Other records listing Medisize BV 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.

K122885MEDISIZE GOLD HEATER AND BOOSTER T-PIECEK081536MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE REDK070714MEDISIZE GOLD HEATER AND BOOSTER

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.

K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare LimitedK254078HVT 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, LP

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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