FDA 510(k)

ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350

K-Number: K052727 · 2005-12-16

Decision Date2005-12-16

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350 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 2005-12-16 under 510(k) number K052727. 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 NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350?

ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350 is a medical device that received FDA 510(k) clearance on 2005-12-16. The listed applicant is Rossmax International , Ltd.. The 510(k) number is K052727.

When did ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350 receive FDA 510(k) clearance?

ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350 received FDA 510(k) clearance on 2005-12-16, under 510(k) number K052727.

Who is the listed applicant for ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350?

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 NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350?

The FDA product code for ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350 is DXN.

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Other records listing Rossmax International , Ltd. as applicant

K060342ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K K021225ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I K013539ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS K013583ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS K011352ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS K011539ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS

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Related Devices (Code: DXN)

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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.