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FDA 510(k)

PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2

K-Number: K023338 · 2003-05-09

ApplicantFms, Finapres Medical Systems BV
Decision Date2003-05-09
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2 is the device name listed in this FDA 510(k) record. The listed applicant is Fms, Finapres Medical Systems BV. It received FDA 510(k) clearance on 2003-05-09 under 510(k) number K023338. 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 PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2?

PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2 is a medical device that received FDA 510(k) clearance on 2003-05-09. The listed applicant is Fms, Finapres Medical Systems BV. The 510(k) number is K023338.

When did PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2 receive FDA 510(k) clearance?

PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2 received FDA 510(k) clearance on 2003-05-09, under 510(k) number K023338.

Who is the listed applicant for PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2?

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

What is the FDA product code for PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2?

The FDA product code for PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2 is DXN.

Related Clinical Trials

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Other records listing Fms, Finapres Medical Systems BV 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.

K023723FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1

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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