FDA 510(k)

Kenz Cardico1211

K-Number: K172068 · 2018-06-01

Decision Date2018-06-01

Product CodeDPS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Kenz Cardico1211 is the device name listed in this FDA 510(k) record. The listed applicant is Suzuken Co., Ltd.. It received FDA 510(k) clearance on 2018-06-01 under 510(k) number K172068. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kenz Cardico1211?

Kenz Cardico1211 is a medical device that received FDA 510(k) clearance on 2018-06-01. The listed applicant is Suzuken Co., Ltd.. The 510(k) number is K172068.

When did Kenz Cardico1211 receive FDA 510(k) clearance?

Kenz Cardico1211 received FDA 510(k) clearance on 2018-06-01, under 510(k) number K172068.

Who is the listed applicant for Kenz Cardico1211?

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

What is the FDA product code for Kenz Cardico1211?

The FDA product code for Kenz Cardico1211 is DPS.

Related Devices (Code: DPS)

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.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)Withings K250569Cardiologs Holter PlatformPhilips France Commercial K243252ZBPro DiagnosticZbeats, 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.