FDA 510(k)

AISAP Cardio V1.0

K-Number: K234141 · 2024-08-01

ApplicantAisap

Decision Date2024-08-01

Product CodePOK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AISAP Cardio V1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Aisap. It received FDA 510(k) clearance on 2024-08-01 under 510(k) number K234141. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AISAP Cardio V1.0?

AISAP Cardio V1.0 is a medical device that received FDA 510(k) clearance on 2024-08-01. The listed applicant is Aisap. The 510(k) number is K234141.

When did AISAP Cardio V1.0 receive FDA 510(k) clearance?

AISAP Cardio V1.0 received FDA 510(k) clearance on 2024-08-01, under 510(k) number K234141.

Who is the listed applicant for AISAP Cardio V1.0?

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

What is the FDA product code for AISAP Cardio V1.0?

The FDA product code for AISAP Cardio V1.0 is POK.

Related Devices (Code: POK)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.