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FDA 510(k)

A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE

K-Number: K072593 · 2007-11-15

ApplicantHealthstats International Pte. , Ltd.
Decision Date2007-11-15
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Healthstats International Pte. , Ltd.. It received FDA 510(k) clearance on 2007-11-15 under 510(k) number K072593. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE?

A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE is a medical device that received FDA 510(k) clearance on 2007-11-15. The listed applicant is Healthstats International Pte. , Ltd.. The 510(k) number is K072593.

When did A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE receive FDA 510(k) clearance?

A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE received FDA 510(k) clearance on 2007-11-15, under 510(k) number K072593.

Who is the listed applicant for A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE?

The FDA 510(k) record lists Healthstats International Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE?

The FDA product code for A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE is DXN.

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.

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Other records listing Healthstats International Pte. , Ltd. 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.

K173028BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC SoftwareK101002A-PULSE CASPRO MODEL T7100, A-PULSE CASPAL MODEL T7200K060315HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEMK051546BPCALIBRATOR MC3000/MC3100

Related Devices (Code: DXN)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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