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FDA 510(k)

ULTRACHECK CURVE BLOOD PRESSURE CUFFS

K-Number: K122365 · 2013-06-04

ApplicantStatcorp Medical
Decision Date2013-06-04
Product CodeOED
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ULTRACHECK CURVE BLOOD PRESSURE CUFFS is the device name listed in this FDA 510(k) record. The listed applicant is Statcorp Medical. It received FDA 510(k) clearance on 2013-06-04 under 510(k) number K122365. The device is classified under product code OED. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACHECK CURVE BLOOD PRESSURE CUFFS?

ULTRACHECK CURVE BLOOD PRESSURE CUFFS is a medical device that received FDA 510(k) clearance on 2013-06-04. The listed applicant is Statcorp Medical. The 510(k) number is K122365.

When did ULTRACHECK CURVE BLOOD PRESSURE CUFFS receive FDA 510(k) clearance?

ULTRACHECK CURVE BLOOD PRESSURE CUFFS received FDA 510(k) clearance on 2013-06-04, under 510(k) number K122365.

Who is the listed applicant for ULTRACHECK CURVE BLOOD PRESSURE CUFFS?

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

What is the FDA product code for ULTRACHECK CURVE BLOOD PRESSURE CUFFS?

The FDA product code for ULTRACHECK CURVE BLOOD PRESSURE CUFFS is OED.

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Related Devices (Code: OED)

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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