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FDA 510(k)

ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46

K-Number: K993432 · 1999-12-20

ApplicantRossmax International , Ltd.
Decision Date1999-12-20
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46 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 1999-12-20 under 510(k) number K993432. 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 AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46?

ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46 is a medical device that received FDA 510(k) clearance on 1999-12-20. The listed applicant is Rossmax International , Ltd.. The 510(k) number is K993432.

When did ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46 receive FDA 510(k) clearance?

ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46 received FDA 510(k) clearance on 1999-12-20, under 510(k) number K993432.

Who is the listed applicant for ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46?

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 AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46?

The FDA product code for ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46 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 1000IK013539ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORSK013583ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 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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