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)

HALO ESPRIT

K-Number: K920117 · 1992-10-06

ApplicantItm Corp.
Decision Date1992-10-06
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HALO ESPRIT is the device name listed in this FDA 510(k) record. The listed applicant is Itm Corp.. It received FDA 510(k) clearance on 1992-10-06 under 510(k) number K920117. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HALO ESPRIT?

HALO ESPRIT is a medical device that received FDA 510(k) clearance on 1992-10-06. The listed applicant is Itm Corp.. The 510(k) number is K920117.

When did HALO ESPRIT receive FDA 510(k) clearance?

HALO ESPRIT received FDA 510(k) clearance on 1992-10-06, under 510(k) number K920117.

Who is the listed applicant for HALO ESPRIT?

The FDA 510(k) record lists Itm Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HALO ESPRIT?

The FDA product code for HALO ESPRIT is JEC.

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: JEC)

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.

K203605SteriTrakArbutus Medical, Inc.K193256Anjon Bremer Halo SystemAnjon Holdings, LLCK192465DigiFix Sterile KitVirak Orthopedics, LLCK181192PIP FixHand Biomechanics Lab, Inc.K171863Anjon Bremer Halo SystemAnjon Holdings, LLCK163028Medline ReNewal Reprocessed Stryker External Fixation DevicesSurgical Instrument Service and Savings, Inc.

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.

↑