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)

DEL MAR AVIONICS 8300 SECTOR IMAGER SYS

K-Number: K844896 · 1985-06-10

ApplicantDel Mar Avionics
Decision Date1985-06-10
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DEL MAR AVIONICS 8300 SECTOR IMAGER SYS is the device name listed in this FDA 510(k) record. The listed applicant is Del Mar Avionics. It received FDA 510(k) clearance on 1985-06-10 under 510(k) number K844896. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEL MAR AVIONICS 8300 SECTOR IMAGER SYS?

DEL MAR AVIONICS 8300 SECTOR IMAGER SYS is a medical device that received FDA 510(k) clearance on 1985-06-10. The listed applicant is Del Mar Avionics. The 510(k) number is K844896.

When did DEL MAR AVIONICS 8300 SECTOR IMAGER SYS receive FDA 510(k) clearance?

DEL MAR AVIONICS 8300 SECTOR IMAGER SYS received FDA 510(k) clearance on 1985-06-10, under 510(k) number K844896.

Who is the listed applicant for DEL MAR AVIONICS 8300 SECTOR IMAGER SYS?

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

What is the FDA product code for DEL MAR AVIONICS 8300 SECTOR IMAGER SYS?

The FDA product code for DEL MAR AVIONICS 8300 SECTOR IMAGER SYS is DXK.

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 Del Mar Avionics 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.

K990027OMNICORDER, MODEL 464K971696SENTINEL RECORDER, MODELS 471/472K963174HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)K950020HOLTER PACERCORDER(R)K942653HOLTER SSR DIGICORDER(TM)K922221SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM

View all 54 devices →

Related Devices (Code: DXK)

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.

K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific CorporationK160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific CorporationK031148IN-VISION IMAGING SYSTEMJomed, Inc.K9348879750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/SK913209ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.

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.

↑