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FDA 510(k)

VITALOGRAPH MODEL 7100 - VITALOJAK

K-Number: K110525 · 2011-11-23

ApplicantVitalograph (Ireland) , Ltd.
Decision Date2011-11-23
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITALOGRAPH MODEL 7100 - VITALOJAK is the device name listed in this FDA 510(k) record. The listed applicant is Vitalograph (Ireland) , Ltd.. It received FDA 510(k) clearance on 2011-11-23 under 510(k) number K110525. 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 VITALOGRAPH MODEL 7100 - VITALOJAK?

VITALOGRAPH MODEL 7100 - VITALOJAK is a medical device that received FDA 510(k) clearance on 2011-11-23. The listed applicant is Vitalograph (Ireland) , Ltd.. The 510(k) number is K110525.

When did VITALOGRAPH MODEL 7100 - VITALOJAK receive FDA 510(k) clearance?

VITALOGRAPH MODEL 7100 - VITALOJAK received FDA 510(k) clearance on 2011-11-23, under 510(k) number K110525.

Who is the listed applicant for VITALOGRAPH MODEL 7100 - VITALOJAK?

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

What is the FDA product code for VITALOGRAPH MODEL 7100 - VITALOJAK?

The FDA product code for VITALOGRAPH MODEL 7100 - VITALOJAK is DSH.

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Other records listing Vitalograph (Ireland) , 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.

K223818Model 9160 VitaloQUBK221030Model 9100 PFT/DICOK212938Vitalograph Model 6000 AlphaK201562SpirotracK200550Vitalograph Model 2120 In2itive eDiaryK160253Vitalograph Model 6300 micro

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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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