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FDA 510(k)

TANGO M2 BLOOD PRESSURE MONITOR

K-Number: K122401 · 2012-11-02

ApplicantSuntech Medical, Inc.
Decision Date2012-11-02
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TANGO M2 BLOOD PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Suntech Medical, Inc.. It received FDA 510(k) clearance on 2012-11-02 under 510(k) number K122401. 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 TANGO M2 BLOOD PRESSURE MONITOR?

TANGO M2 BLOOD PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 2012-11-02. The listed applicant is Suntech Medical, Inc.. The 510(k) number is K122401.

When did TANGO M2 BLOOD PRESSURE MONITOR receive FDA 510(k) clearance?

TANGO M2 BLOOD PRESSURE MONITOR received FDA 510(k) clearance on 2012-11-02, under 510(k) number K122401.

Who is the listed applicant for TANGO M2 BLOOD PRESSURE MONITOR?

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

What is the FDA product code for TANGO M2 BLOOD PRESSURE MONITOR?

The FDA product code for TANGO M2 BLOOD PRESSURE MONITOR is DXN.

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Other records listing Suntech Medical, Inc. as applicant

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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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