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FDA 510(k)

CARDIOLIGHT

K-Number: K982448 · 1999-06-11

ApplicantCapintec, Inc.
Decision Date1999-06-11
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOLIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Capintec, Inc.. It received FDA 510(k) clearance on 1999-06-11 under 510(k) number K982448. 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 CARDIOLIGHT?

CARDIOLIGHT is a medical device that received FDA 510(k) clearance on 1999-06-11. The listed applicant is Capintec, Inc.. The 510(k) number is K982448.

When did CARDIOLIGHT receive FDA 510(k) clearance?

CARDIOLIGHT received FDA 510(k) clearance on 1999-06-11, under 510(k) number K982448.

Who is the listed applicant for CARDIOLIGHT?

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

What is the FDA product code for CARDIOLIGHT?

The FDA product code for CARDIOLIGHT 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

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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