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FDA 510(k)

ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS

K-Number: K011539 · 2001-07-20

ApplicantRossmax International , Ltd.
Decision Date2001-07-20
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS is the device name listed in this FDA 510(k) record. The listed applicant is Rossmax International , Ltd.. It received FDA 510(k) clearance on 2001-07-20 under 510(k) number K011539. 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 ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS?

ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS is a medical device that received FDA 510(k) clearance on 2001-07-20. The listed applicant is Rossmax International , Ltd.. The 510(k) number is K011539.

When did ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS receive FDA 510(k) clearance?

ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS received FDA 510(k) clearance on 2001-07-20, under 510(k) number K011539.

Who is the listed applicant for ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS?

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

What is the FDA product code for ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS?

The FDA product code for ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS is DXN.

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Other records listing Rossmax International , 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.

K060342ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701KK052727ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350K021225ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000IK013583ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORSK013539ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORSK011352ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS

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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

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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