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FDA 510(k)

UNICUF, BLOOD PRESSURE CUFF

K-Number: K801099 · 1980-05-30

ApplicantFrontier Products
Decision Date1980-05-30
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNICUF, 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 1980-05-30 under 510(k) number K801099. 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 UNICUF, BLOOD PRESSURE CUFF?

UNICUF, BLOOD PRESSURE CUFF is a medical device that received FDA 510(k) clearance on 1980-05-30. The listed applicant is Frontier Products. The 510(k) number is K801099.

When did UNICUF, BLOOD PRESSURE CUFF receive FDA 510(k) clearance?

UNICUF, BLOOD PRESSURE CUFF received FDA 510(k) clearance on 1980-05-30, under 510(k) number K801099.

Who is the listed applicant for UNICUF, 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 UNICUF, BLOOD PRESSURE CUFF?

The FDA product code for UNICUF, 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.

K831001UNICUFF-BLOOD PRESSURE CUFFK822305ORTHO-LEVELK812639UNICUFF

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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