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FDA 510(k)

D SERIES ELECTRODE

K-Number: K970603 · 1997-04-01

ApplicantCmc Sense-It, Inc.
Decision Date1997-04-01
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

D SERIES ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Cmc Sense-It, Inc.. It received FDA 510(k) clearance on 1997-04-01 under 510(k) number K970603. 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 D SERIES ELECTRODE?

D SERIES ELECTRODE is a medical device that received FDA 510(k) clearance on 1997-04-01. The listed applicant is Cmc Sense-It, Inc.. The 510(k) number is K970603.

When did D SERIES ELECTRODE receive FDA 510(k) clearance?

D SERIES ELECTRODE received FDA 510(k) clearance on 1997-04-01, under 510(k) number K970603.

Who is the listed applicant for D SERIES ELECTRODE?

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

What is the FDA product code for D SERIES ELECTRODE?

The FDA product code for D SERIES ELECTRODE 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 Cmc Sense-It, 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.

K963159CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODESK955815G3000 OR AG2000; DISPOSABLE RESTING ELECTRODEK955800SI2000 (SENSE-IT TRADEMARK) OR G2000; DISPOSABLE RESTING ELECTRODE

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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