Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MEDISIZE GOLD HEATER AND BOOSTER T-PIECE

K-Number: K122885 · 2013-08-29

ApplicantMedisize BV
Decision Date2013-08-29
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDISIZE GOLD HEATER AND BOOSTER T-PIECE is the device name listed in this FDA 510(k) record. The listed applicant is Medisize BV. It received FDA 510(k) clearance on 2013-08-29 under 510(k) number K122885. 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 HEATER AND BOOSTER T-PIECE?

MEDISIZE GOLD HEATER AND BOOSTER T-PIECE is a medical device that received FDA 510(k) clearance on 2013-08-29. The listed applicant is Medisize BV. The 510(k) number is K122885.

When did MEDISIZE GOLD HEATER AND BOOSTER T-PIECE receive FDA 510(k) clearance?

MEDISIZE GOLD HEATER AND BOOSTER T-PIECE received FDA 510(k) clearance on 2013-08-29, under 510(k) number K122885.

Who is the listed applicant for MEDISIZE GOLD HEATER AND BOOSTER T-PIECE?

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 HEATER AND BOOSTER T-PIECE?

The FDA product code for MEDISIZE GOLD HEATER AND BOOSTER T-PIECE is BTT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K081536MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE REDK070714MEDISIZE GOLD HEATER AND BOOSTERK052615MEDISIZE GOLD

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.

↑