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FDA 510(k)

Ablamap Software

K-Number: K203084 · 2021-08-31

ApplicantAblacon, Inc.
Decision Date2021-08-31
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Ablamap Software is the device name listed in this FDA 510(k) record. The listed applicant is Ablacon, Inc.. It received FDA 510(k) clearance on 2021-08-31 under 510(k) number K203084. 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 Ablamap Software?

Ablamap Software is a medical device that received FDA 510(k) clearance on 2021-08-31. The listed applicant is Ablacon, Inc.. The 510(k) number is K203084.

When did Ablamap Software receive FDA 510(k) clearance?

Ablamap Software received FDA 510(k) clearance on 2021-08-31, under 510(k) number K203084.

Who is the listed applicant for Ablamap Software?

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

What is the FDA product code for Ablamap Software?

The FDA product code for Ablamap Software is DQK.

Other records listing Ablacon, Inc. 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.

K230008Ablamap® SystemK223666Ablacath™ Mapping Catheter

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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