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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 a medical device manufactured by Aisap. It received FDA 510(k) clearance on 2024-08-01 under approval 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. It is manufactured by Aisap. The 510(k) number is K234141.

When was AISAP Cardio V1.0 approved by the FDA?

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

What company makes AISAP Cardio V1.0?

AISAP Cardio V1.0 is manufactured by Aisap.

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

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

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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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