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FDA 510(k)

MODIFIED CARDIOCAP MONITOR

K-Number: K862455 · 1986-09-24

ApplicantDatex Division Instrumentarium Corp.
Decision Date1986-09-24
Product CodeDSK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED CARDIOCAP MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Datex Division Instrumentarium Corp.. It received FDA 510(k) clearance on 1986-09-24 under 510(k) number K862455. The device is classified under product code DSK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED CARDIOCAP MONITOR?

MODIFIED CARDIOCAP MONITOR is a medical device that received FDA 510(k) clearance on 1986-09-24. The listed applicant is Datex Division Instrumentarium Corp.. The 510(k) number is K862455.

When did MODIFIED CARDIOCAP MONITOR receive FDA 510(k) clearance?

MODIFIED CARDIOCAP MONITOR received FDA 510(k) clearance on 1986-09-24, under 510(k) number K862455.

Who is the listed applicant for MODIFIED CARDIOCAP MONITOR?

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

What is the FDA product code for MODIFIED CARDIOCAP MONITOR?

The FDA product code for MODIFIED CARDIOCAP MONITOR is DSK.

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Other records listing Datex Division Instrumentarium Corp. 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.

K953175AS/3 ESTPR MODULEK961247AS/3 LIGHT MONITORK943458AS/3 AIRWAY MODULEK945234AS/3 MEMORY MODULE, M0MEMK933156DATEX AS/3 PATIENT MONITORK933285DATEX AS/3 TM ANAESTHESIA MONITOR

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Related Devices (Code: DSK)

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.

K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLCK160945Endophys Blood Pressure MonitorEndophys Holdings, LLCK080670MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor MedicalK070795SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor Medical Pty, Ltd.K033738MONITORING SYSTEM, MODEL ARGUS PB-2200Schiller AGK021517ABP FOR WINDOWSRozinn Electronics, 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.

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