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)

VAPOTHERM, MODEL 2000I

K-Number: K000401 · 2000-08-24

ApplicantVapotherm, Inc.
Decision Date2000-08-24
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VAPOTHERM, MODEL 2000I is the device name listed in this FDA 510(k) record. The listed applicant is Vapotherm, Inc.. It received FDA 510(k) clearance on 2000-08-24 under 510(k) number K000401. 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 VAPOTHERM, MODEL 2000I?

VAPOTHERM, MODEL 2000I is a medical device that received FDA 510(k) clearance on 2000-08-24. The listed applicant is Vapotherm, Inc.. The 510(k) number is K000401.

When did VAPOTHERM, MODEL 2000I receive FDA 510(k) clearance?

VAPOTHERM, MODEL 2000I received FDA 510(k) clearance on 2000-08-24, under 510(k) number K000401.

Who is the listed applicant for VAPOTHERM, MODEL 2000I?

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

What is the FDA product code for VAPOTHERM, MODEL 2000I?

The FDA product code for VAPOTHERM, MODEL 2000I 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 Vapotherm, Inc. 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.

K254078HVT 2.0K221318HVT 2.0K220869Vapotherm Aerosol Adapter AAA-2K203357HVT 2.0K191010Palladium High Flow Therapy SystemK111640PRECISION FLOW(R) - HELIOX

View all 12 devices →

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.

↑