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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 a medical device manufactured by Ablacon, Inc.. It received FDA 510(k) clearance on 2021-08-31 under approval 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. It is manufactured by Ablacon, Inc.. The 510(k) number is K203084.

When was Ablamap Software approved by the FDA?

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

What company makes Ablamap Software?

Ablamap Software is manufactured by Ablacon, Inc..

What is the FDA product code for Ablamap Software?

The FDA product code for Ablamap Software is DQK.

Other Devices by Ablacon, Inc.

K230008Ablamap® System K223666Ablacath™ Mapping Catheter

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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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