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)

CARDISUNY, 501BX

K-Number: K900849 · 1990-04-04

ApplicantGraham-Field, Inc.
Decision Date1990-04-04
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

CARDISUNY, 501BX is the device name listed in this FDA 510(k) record. The listed applicant is Graham-Field, Inc.. It received FDA 510(k) clearance on 1990-04-04 under 510(k) number K900849. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDISUNY, 501BX?

CARDISUNY, 501BX is a medical device that received FDA 510(k) clearance on 1990-04-04. The listed applicant is Graham-Field, Inc.. The 510(k) number is K900849.

When did CARDISUNY, 501BX receive FDA 510(k) clearance?

CARDISUNY, 501BX received FDA 510(k) clearance on 1990-04-04, under 510(k) number K900849.

Who is the listed applicant for CARDISUNY, 501BX?

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

What is the FDA product code for CARDISUNY, 501BX?

The FDA product code for CARDISUNY, 501BX 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 Graham-Field, 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.

K970035JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009K961857LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060K924876TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIEDK904904MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATIONK901948CARDISUNY 501BIIIK901947CARDISUNY 501AB

View all 8 devices →

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.

↑