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)

TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)

K-Number: K962128 · 1996-11-21

ApplicantHemo Sapiens, Inc.
Decision Date1996-11-21
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT) is the device name listed in this FDA 510(k) record. The listed applicant is Hemo Sapiens, Inc.. It received FDA 510(k) clearance on 1996-11-21 under 510(k) number K962128. 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 TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)?

TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT) is a medical device that received FDA 510(k) clearance on 1996-11-21. The listed applicant is Hemo Sapiens, Inc.. The 510(k) number is K962128.

When did TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT) receive FDA 510(k) clearance?

TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT) received FDA 510(k) clearance on 1996-11-21, under 510(k) number K962128.

Who is the listed applicant for TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)?

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

What is the FDA product code for TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)?

The FDA product code for TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT) 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 Hemo Sapiens, 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.

K952172HOTMAN

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.

↑