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FDA 510(k)

TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM

K-Number: K053209 · 2006-01-05

ApplicantSuntech Medical, Inc.
Decision Date2006-01-05
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM 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 2006-01-05 under 510(k) number K053209. 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+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM?

TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2006-01-05. The listed applicant is Suntech Medical, Inc.. The 510(k) number is K053209.

When did TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM receive FDA 510(k) clearance?

TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM received FDA 510(k) clearance on 2006-01-05, under 510(k) number K053209.

Who is the listed applicant for TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM?

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+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM?

The FDA product code for TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM is DXN.

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Other records listing Suntech Medical, Inc. 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.

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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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