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)

MODEL 503FB

K-Number: K842759 · 1985-01-18

ApplicantAtrix
Decision Date1985-01-18
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

MODEL 503FB is the device name listed in this FDA 510(k) record. The listed applicant is Atrix. It received FDA 510(k) clearance on 1985-01-18 under 510(k) number K842759. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 503FB?

MODEL 503FB is a medical device that received FDA 510(k) clearance on 1985-01-18. The listed applicant is Atrix. The 510(k) number is K842759.

When did MODEL 503FB receive FDA 510(k) clearance?

MODEL 503FB received FDA 510(k) clearance on 1985-01-18, under 510(k) number K842759.

Who is the listed applicant for MODEL 503FB?

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

What is the FDA product code for MODEL 503FB?

The FDA product code for MODEL 503FB is LOS.

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 Atrix 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.

K852829CARDISUNY 501 A

Related Devices (Code: LOS)

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.

K090895EKG-PLUS II SOFTWAREBionet Co., Ltd.K083749CARDIOVIEW32 REVIEW MODULEQrs Diagnostic, LLCK073376PHILIPS ECG ALGORITHMPhilips Medical SystemsK023034CARDIOTOUCH-3000Bionet Company, Ltd.K011328CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPHBionet Company, Ltd.K993616CARDIO-CARD INTERPRETATION SYSTEM INasiff Assoc., 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.

↑