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FDA 510(k)

RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF

K-Number: K123996 · 2013-04-09

ApplicantGe Medical Systems Information Technologies, Inc.
Decision Date2013-04-09
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2013-04-09 under 510(k) number K123996. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF?

RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF is a medical device that received FDA 510(k) clearance on 2013-04-09. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K123996.

When did RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF receive FDA 510(k) clearance?

RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF received FDA 510(k) clearance on 2013-04-09, under 510(k) number K123996.

Who is the listed applicant for RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF?

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

What is the FDA product code for RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF?

The FDA product code for RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF is DXQ.

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Related Devices (Code: DXQ)

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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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