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)

CONVERTER UNIT FOR ECG TRACE DISPLAY

K-Number: K830566 · 1983-05-25

ApplicantHoneywell, Inc.
Decision Date1983-05-25
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CONVERTER UNIT FOR ECG TRACE DISPLAY is the device name listed in this FDA 510(k) record. The listed applicant is Honeywell, Inc.. It received FDA 510(k) clearance on 1983-05-25 under 510(k) number K830566. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONVERTER UNIT FOR ECG TRACE DISPLAY?

CONVERTER UNIT FOR ECG TRACE DISPLAY is a medical device that received FDA 510(k) clearance on 1983-05-25. The listed applicant is Honeywell, Inc.. The 510(k) number is K830566.

When did CONVERTER UNIT FOR ECG TRACE DISPLAY receive FDA 510(k) clearance?

CONVERTER UNIT FOR ECG TRACE DISPLAY received FDA 510(k) clearance on 1983-05-25, under 510(k) number K830566.

Who is the listed applicant for CONVERTER UNIT FOR ECG TRACE DISPLAY?

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

What is the FDA product code for CONVERTER UNIT FOR ECG TRACE DISPLAY?

The FDA product code for CONVERTER UNIT FOR ECG TRACE DISPLAY is DPS.

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 Honeywell, 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.

K902230COLORADO COLOR IMAGING RECORDERK863100CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECORK853501HONEYWELL ELECTRONIC VENTILATOR EV-AK855125PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEMK851888APM DISPOS. BLOOD PRESSURE TRANSDUCERK851496ECG MONITOR MODEL RM102

View all 69 devices →

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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.

↑