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)

STS RANGE , MODELS STS20,STS30,STS40

K-Number: K012008 · 2001-09-21

ApplicantHuntleigh Healthcare, Inc.
Decision Date2001-09-21
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STS RANGE , MODELS STS20,STS30,STS40 is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare, Inc.. It received FDA 510(k) clearance on 2001-09-21 under 510(k) number K012008. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STS RANGE , MODELS STS20,STS30,STS40?

STS RANGE , MODELS STS20,STS30,STS40 is a medical device that received FDA 510(k) clearance on 2001-09-21. The listed applicant is Huntleigh Healthcare, Inc.. The 510(k) number is K012008.

When did STS RANGE , MODELS STS20,STS30,STS40 receive FDA 510(k) clearance?

STS RANGE , MODELS STS20,STS30,STS40 received FDA 510(k) clearance on 2001-09-21, under 510(k) number K012008.

Who is the listed applicant for STS RANGE , MODELS STS20,STS30,STS40?

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

What is the FDA product code for STS RANGE , MODELS STS20,STS30,STS40?

The FDA product code for STS RANGE , MODELS STS20,STS30,STS40 is JOW.

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 Huntleigh Healthcare, 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.

K032315IOP8 INTRA OPERATIVE PROBEK022786DVT60K010744FLOWTRON UNIVERSAL, MODEL AC600K002186VASCULAR ASSISTK010889BABY DOPPLEX 3000 MK 2 (BD3000)K010894BABY DOPPLEX 3002 (BD3002)

View all 14 devices →

Related Devices (Code: JOW)

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.

K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.

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.

↑