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FDA 510(k)

DATA IV AMBULATORY MONITOR

K-Number: K831262 · 1983-05-25

ApplicantCardio-Scan of Texas
Decision Date1983-05-25
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DATA IV AMBULATORY MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Cardio-Scan of Texas. It received FDA 510(k) clearance on 1983-05-25 under 510(k) number K831262. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DATA IV AMBULATORY MONITOR?

DATA IV AMBULATORY MONITOR is a medical device that received FDA 510(k) clearance on 1983-05-25. The listed applicant is Cardio-Scan of Texas. The 510(k) number is K831262.

When did DATA IV AMBULATORY MONITOR receive FDA 510(k) clearance?

DATA IV AMBULATORY MONITOR received FDA 510(k) clearance on 1983-05-25, under 510(k) number K831262.

Who is the listed applicant for DATA IV AMBULATORY MONITOR?

The FDA 510(k) record lists Cardio-Scan of Texas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DATA IV AMBULATORY MONITOR?

The FDA product code for DATA IV AMBULATORY MONITOR is DSH.

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Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., 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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