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FDA 510(k)

ZOLL ECG Analysis Software

K-Number: K182093 · 2019-01-28

ApplicantZoll Manufacturing Corporation
Decision Date2019-01-28
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOLL ECG Analysis Software is the device name listed in this FDA 510(k) record. The listed applicant is Zoll Manufacturing Corporation. It received FDA 510(k) clearance on 2019-01-28 under 510(k) number K182093. 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 ZOLL ECG Analysis Software?

ZOLL ECG Analysis Software is a medical device that received FDA 510(k) clearance on 2019-01-28. The listed applicant is Zoll Manufacturing Corporation. The 510(k) number is K182093.

When did ZOLL ECG Analysis Software receive FDA 510(k) clearance?

ZOLL ECG Analysis Software received FDA 510(k) clearance on 2019-01-28, under 510(k) number K182093.

Who is the listed applicant for ZOLL ECG Analysis Software?

The FDA 510(k) record lists Zoll Manufacturing Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZOLL ECG Analysis Software?

The FDA product code for ZOLL ECG Analysis Software is DPS.

Other records listing Zoll Manufacturing Corporation 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.

PMA P010030Wearable automated external defibrillatorK190939ZOLL Arrhythmia Management SysyemK172510µCor Heart Failure and Arrhythmia Management System

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)WithingsK250569Cardiologs Holter PlatformPhilips France CommercialK243252ZBPro DiagnosticZbeats, Inc.

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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