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FDA 510(k)

EndoPATx

K-Number: K211557 · 2022-12-29

ApplicantItamar Medical , Ltd.
Decision Date2022-12-29
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EndoPATx is the device name listed in this FDA 510(k) record. The listed applicant is Itamar Medical , Ltd.. It received FDA 510(k) clearance on 2022-12-29 under 510(k) number K211557. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoPATx?

EndoPATx is a medical device that received FDA 510(k) clearance on 2022-12-29. The listed applicant is Itamar Medical , Ltd.. The 510(k) number is K211557.

When did EndoPATx receive FDA 510(k) clearance?

EndoPATx received FDA 510(k) clearance on 2022-12-29, under 510(k) number K211557.

Who is the listed applicant for EndoPATx?

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

What is the FDA product code for EndoPATx?

The FDA product code for EndoPATx is DQK.

Other records listing Itamar Medical , 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.

K254042WatchPAT SWK250460WatchPAT400 (WP400)K223675WatchPAT ONE (WP1)K222331WatchPAT300 (WP300)K203839WatchPAT200U (WP200U)K183559WatchPAT ONE

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Related Devices (Code: DQK)

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.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, 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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