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)

HEMOSONIC 200HEMODYNAMIC MONITOR

K-Number: K040802 · 2004-04-28

ApplicantArrow Intl., Inc.
Decision Date2004-04-28
Product CodeDPN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

HEMOSONIC 200HEMODYNAMIC MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Intl., Inc.. It received FDA 510(k) clearance on 2004-04-28 under 510(k) number K040802. The device is classified under product code DPN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOSONIC 200HEMODYNAMIC MONITOR?

HEMOSONIC 200HEMODYNAMIC MONITOR is a medical device that received FDA 510(k) clearance on 2004-04-28. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K040802.

When did HEMOSONIC 200HEMODYNAMIC MONITOR receive FDA 510(k) clearance?

HEMOSONIC 200HEMODYNAMIC MONITOR received FDA 510(k) clearance on 2004-04-28, under 510(k) number K040802.

Who is the listed applicant for HEMOSONIC 200HEMODYNAMIC MONITOR?

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

What is the FDA product code for HEMOSONIC 200HEMODYNAMIC MONITOR?

The FDA product code for HEMOSONIC 200HEMODYNAMIC MONITOR is DPN.

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 Arrow Intl., 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.

K100635ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504K093050ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520K071491ARROW INTERNATIONAL, INC., SURGICAL DRAPESK071998ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENTK071111NON-ABSORBABLE SILK SUTUREK060309AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES

View all 110 devices →

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.

↑