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FDA 510(k)

ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM

K-Number: K050858 · 2005-06-29

ApplicantHeartlab, Inc.
Decision Date2005-06-29
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Heartlab, Inc.. It received FDA 510(k) clearance on 2005-06-29 under 510(k) number K050858. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM?

ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2005-06-29. The listed applicant is Heartlab, Inc.. The 510(k) number is K050858.

When did ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM receive FDA 510(k) clearance?

ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM received FDA 510(k) clearance on 2005-06-29, under 510(k) number K050858.

Who is the listed applicant for ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM?

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

What is the FDA product code for ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM?

The FDA product code for ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM is DPS.

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 Heartlab, 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.

K050228AGFA HEARTLAB CARDIOVASCULARK042042ULTRASOUND CAPTURE SYSTEMK040896MODIFICATION TO ENCOMPASSK954479DICOMVIEWK954860ECHONET

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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.

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