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FDA 510(k)

CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE

K-Number: K081924 · 2009-01-07

ApplicantCalhealth, Inc.
Decision Date2009-01-07
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE is the device name listed in this FDA 510(k) record. The listed applicant is Calhealth, Inc.. It received FDA 510(k) clearance on 2009-01-07 under 510(k) number K081924. 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 CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE?

CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE is a medical device that received FDA 510(k) clearance on 2009-01-07. The listed applicant is Calhealth, Inc.. The 510(k) number is K081924.

When did CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE receive FDA 510(k) clearance?

CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE received FDA 510(k) clearance on 2009-01-07, under 510(k) number K081924.

Who is the listed applicant for CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE?

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

What is the FDA product code for CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE?

The FDA product code for CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE is DXN.

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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

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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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