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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 a medical device manufactured by Zoll Manufacturing Corporation. It received FDA 510(k) clearance on 2019-01-28 under approval 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. It is manufactured by Zoll Manufacturing Corporation. The 510(k) number is K182093.

When was ZOLL ECG Analysis Software approved by the FDA?

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

What company makes ZOLL ECG Analysis Software?

ZOLL ECG Analysis Software is manufactured by Zoll Manufacturing Corporation.

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41714355 The AI Act and the MDR post-market requirements for semiautonomous AI SaMD: a radiology case study in prostate cancer. Abdominal radiology (New York) (2026) PMID: 41533310 Scoping review of regulatory transparency in AI-based radiology software: analysis of PMDA-approved SaMD products. Japanese journal of radiology (2026) PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026)

Other Devices by Zoll Manufacturing Corporation

K172510µCor Heart Failure and Arrhythmia Management System K190939ZOLL Arrhythmia Management Sysyem PMA P010030Wearable automated external defibrillator

Related Devices (Code: DPS)

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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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