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)

INFINITY PICCO POD, MODEL MS16734

K-Number: K073113 · 2008-01-03

ApplicantDraeger Medical Systems, Inc.
Decision Date2008-01-03
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INFINITY PICCO POD, MODEL MS16734 is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2008-01-03 under 510(k) number K073113. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINITY PICCO POD, MODEL MS16734?

INFINITY PICCO POD, MODEL MS16734 is a medical device that received FDA 510(k) clearance on 2008-01-03. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K073113.

When did INFINITY PICCO POD, MODEL MS16734 receive FDA 510(k) clearance?

INFINITY PICCO POD, MODEL MS16734 received FDA 510(k) clearance on 2008-01-03, under 510(k) number K073113.

Who is the listed applicant for INFINITY PICCO POD, MODEL MS16734?

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

What is the FDA product code for INFINITY PICCO POD, MODEL MS16734?

The FDA product code for INFINITY PICCO POD, MODEL MS16734 is DXG.

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 Draeger Medical Systems, 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.

K260579Infinity® Acute Care System (IACS) – VG8.1K243606Babyroo TN300K240312Infinity CentralStation WideK233834Infinity Gateway SuiteK231477Infinity CentralStation Wide, Infinity M300, Infinity M300+K230278Babyroo TN300

View all 45 devices →

Related Devices (Code: DXG)

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.

K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.K251275VitalStream ART Connect; VitalStream-HemoCaretaker MedicalK232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu MedicalK212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd.K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SEK193179EV1000 Clinical PlatformEdwards Lifesciences, LLC

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.

↑