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FDA 510(k)

UNICUFF

K-Number: K812639 · 1981-10-02

ApplicantFrontier Products
Decision Date1981-10-02
Product CodeDXP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNICUFF is the device name listed in this FDA 510(k) record. The listed applicant is Frontier Products. It received FDA 510(k) clearance on 1981-10-02 under 510(k) number K812639. The device is classified under product code DXP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNICUFF?

UNICUFF is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is Frontier Products. The 510(k) number is K812639.

When did UNICUFF receive FDA 510(k) clearance?

UNICUFF received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812639.

Who is the listed applicant for UNICUFF?

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

What is the FDA product code for UNICUFF?

The FDA product code for UNICUFF is DXP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Frontier Products 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.

K831001UNICUFF-BLOOD PRESSURE CUFFK822305ORTHO-LEVELK801099UNICUF, BLOOD PRESSURE CUFF

Related Devices (Code: DXP)

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.

K891180TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KITIngress Technologies, Inc.

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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