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FDA 510(k)

HEART RATE COMPUTER STRIP CHART

K-Number: K791927 · 1979-11-13

ApplicantStanford Assoc., Inc.
Decision Date1979-11-13
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART RATE COMPUTER STRIP CHART is the device name listed in this FDA 510(k) record. The listed applicant is Stanford Assoc., Inc.. It received FDA 510(k) clearance on 1979-11-13 under 510(k) number K791927. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEART RATE COMPUTER STRIP CHART?

HEART RATE COMPUTER STRIP CHART is a medical device that received FDA 510(k) clearance on 1979-11-13. The listed applicant is Stanford Assoc., Inc.. The 510(k) number is K791927.

When did HEART RATE COMPUTER STRIP CHART receive FDA 510(k) clearance?

HEART RATE COMPUTER STRIP CHART received FDA 510(k) clearance on 1979-11-13, under 510(k) number K791927.

Who is the listed applicant for HEART RATE COMPUTER STRIP CHART?

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

What is the FDA product code for HEART RATE COMPUTER STRIP CHART?

The FDA product code for HEART RATE COMPUTER STRIP CHART is JOM.

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 Stanford Assoc., 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.

K791862HEART RATE COMPUTER

Related Devices (Code: JOM)

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.

K220527PADnet XpressCollaborative Care Diagnostics, LLC, D.B.A. BiomedixK213730MESI mTABLET TBI diagnostic system, MESI mTABLET TBIMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.K200567ASI Plethysmogrpah AnalyzerArterial Stiffness, Inc.K201046Automated ankle brachial pressure index measuring device, MESI mTABLET systemMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.K191266VitalScan ANSMedeia, Inc.K172655Automated ankle brachial pressure index measuring deviceMesi D.O.O.; Mesi, Development of Medical Devices, 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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