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FDA 510(k)

UNICUFF-BLOOD PRESSURE CUFF

K-Number: K831001 · 1983-07-28

ApplicantFrontier Products
Decision Date1983-07-28
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNICUFF-BLOOD PRESSURE CUFF is the device name listed in this FDA 510(k) record. The listed applicant is Frontier Products. It received FDA 510(k) clearance on 1983-07-28 under 510(k) number K831001. 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 UNICUFF-BLOOD PRESSURE CUFF?

UNICUFF-BLOOD PRESSURE CUFF is a medical device that received FDA 510(k) clearance on 1983-07-28. The listed applicant is Frontier Products. The 510(k) number is K831001.

When did UNICUFF-BLOOD PRESSURE CUFF receive FDA 510(k) clearance?

UNICUFF-BLOOD PRESSURE CUFF received FDA 510(k) clearance on 1983-07-28, under 510(k) number K831001.

Who is the listed applicant for UNICUFF-BLOOD PRESSURE CUFF?

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-BLOOD PRESSURE CUFF?

The FDA product code for UNICUFF-BLOOD PRESSURE CUFF is DXQ.

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.

K822305ORTHO-LEVELK812639UNICUFFK801099UNICUF, BLOOD PRESSURE CUFF

Related Devices (Code: DXQ)

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.

K254287Medline Reusable Blood Pressure CuffMedline Industries, LPK260747YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffNihon Kohden CorporationK253089NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)Shenzhen Best Electronics Co., Ltd.K253964Disposable Neonatal NIBP Cuff (U1681S-C51N)Unimed Medical Supplies, Inc.K251745Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)Baxter Healthcare CorporationK250765AViTA Arm Type Blood Pressure Monitor CuffAvita Corporation

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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