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)

COMPASS COMPRESSION ASSIST HANDLE

K-Number: K053398 · 2006-03-10

ApplicantSemler Technologies, Inc. Dba
Decision Date2006-03-10
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COMPASS COMPRESSION ASSIST HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is Semler Technologies, Inc. Dba. It received FDA 510(k) clearance on 2006-03-10 under 510(k) number K053398. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPASS COMPRESSION ASSIST HANDLE?

COMPASS COMPRESSION ASSIST HANDLE is a medical device that received FDA 510(k) clearance on 2006-03-10. The listed applicant is Semler Technologies, Inc. Dba. The 510(k) number is K053398.

When did COMPASS COMPRESSION ASSIST HANDLE receive FDA 510(k) clearance?

COMPASS COMPRESSION ASSIST HANDLE received FDA 510(k) clearance on 2006-03-10, under 510(k) number K053398.

Who is the listed applicant for COMPASS COMPRESSION ASSIST HANDLE?

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

What is the FDA product code for COMPASS COMPRESSION ASSIST HANDLE?

The FDA product code for COMPASS COMPRESSION ASSIST HANDLE is DXC.

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

Related Devices (Code: DXC)

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.

K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards LifesciencesK252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060Life Saving TourniquetTW MedicalK243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLCK253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP

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.

↑