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FDA 510(k)

ADDITIONAL SOFTWARE TO CARDIODYNAMIC MONITOR

K-Number: K890408 · 1989-06-01

ApplicantBomed Medical Mfg., Ltd.
Decision Date1989-06-01
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADDITIONAL SOFTWARE TO CARDIODYNAMIC MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Bomed Medical Mfg., Ltd.. It received FDA 510(k) clearance on 1989-06-01 under 510(k) number K890408. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADDITIONAL SOFTWARE TO CARDIODYNAMIC MONITOR?

ADDITIONAL SOFTWARE TO CARDIODYNAMIC MONITOR is a medical device that received FDA 510(k) clearance on 1989-06-01. The listed applicant is Bomed Medical Mfg., Ltd.. The 510(k) number is K890408.

When did ADDITIONAL SOFTWARE TO CARDIODYNAMIC MONITOR receive FDA 510(k) clearance?

ADDITIONAL SOFTWARE TO CARDIODYNAMIC MONITOR received FDA 510(k) clearance on 1989-06-01, under 510(k) number K890408.

Who is the listed applicant for ADDITIONAL SOFTWARE TO CARDIODYNAMIC MONITOR?

The FDA 510(k) record lists Bomed Medical Mfg., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADDITIONAL SOFTWARE TO CARDIODYNAMIC MONITOR?

The FDA product code for ADDITIONAL SOFTWARE TO CARDIODYNAMIC MONITOR is DSB.

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.

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Other records listing Bomed Medical Mfg., Ltd. 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.

K900213PACEMAKER PATIENT ADAPTOR MODULE (PPAM)

Related Devices (Code: DSB)

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.

K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed LimitedK250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLCK243727Re:BalansMode Sensors ASK250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed LimitedK223217Zynex Monitoring System, Model CM-1600Zynex Medical, Inc.

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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