Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

THIGH CUFF: X-LARGE CUFF

K-Number: K813323 · 1981-12-29

ApplicantAbco Dealers, Inc.
Decision Date1981-12-29
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THIGH CUFF: X-LARGE CUFF is the device name listed in this FDA 510(k) record. The listed applicant is Abco Dealers, Inc.. It received FDA 510(k) clearance on 1981-12-29 under 510(k) number K813323. 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 THIGH CUFF: X-LARGE CUFF?

THIGH CUFF: X-LARGE CUFF is a medical device that received FDA 510(k) clearance on 1981-12-29. The listed applicant is Abco Dealers, Inc.. The 510(k) number is K813323.

When did THIGH CUFF: X-LARGE CUFF receive FDA 510(k) clearance?

THIGH CUFF: X-LARGE CUFF received FDA 510(k) clearance on 1981-12-29, under 510(k) number K813323.

Who is the listed applicant for THIGH CUFF: X-LARGE CUFF?

The FDA 510(k) record lists Abco Dealers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THIGH CUFF: X-LARGE CUFF?

The FDA product code for THIGH CUFF: X-LARGE 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 Abco Dealers, Inc. 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.

K905025DIGITAL THERMOMETER KITSK882304DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)K880892BLOOD COLLECTING NEEDLE AND HOLDERSK880894ALLERGIST SYRINGESK872875STRETCH GAUZE BANDAGESK872874MICROSCOPE COVER GLASSES

View all 127 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑