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FDA 510(k)

ECG PATIENT MONITOR

K-Number: K843376 · 1984-12-27

ApplicantRigel Medical Electronics, Inc.
Decision Date1984-12-27
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG PATIENT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Rigel Medical Electronics, Inc.. It received FDA 510(k) clearance on 1984-12-27 under 510(k) number K843376. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECG PATIENT MONITOR?

ECG PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 1984-12-27. The listed applicant is Rigel Medical Electronics, Inc.. The 510(k) number is K843376.

When did ECG PATIENT MONITOR receive FDA 510(k) clearance?

ECG PATIENT MONITOR received FDA 510(k) clearance on 1984-12-27, under 510(k) number K843376.

Who is the listed applicant for ECG PATIENT MONITOR?

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

What is the FDA product code for ECG PATIENT MONITOR?

The FDA product code for ECG PATIENT MONITOR is DRT.

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 Rigel Medical Electronics, 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.

K884645PATIENT MONITOR RIGEL MODEL MULTICARE 429K875160RIGEL MODEL MULTICARE 409K850407NEONATAL MONITOR 309K850156ECG PATIENT MONITOR 301K850155ECG PATIENT MONITOR 302

Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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