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FDA 510(k)

PROWLER SELECT PLUS; PROWLER EX

K-Number: K210838 · 2021-08-25

ApplicantMedos International SARL
Decision Date2021-08-25
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROWLER SELECT PLUS; PROWLER EX is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2021-08-25 under approval number K210838. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROWLER SELECT PLUS; PROWLER EX?

PROWLER SELECT PLUS; PROWLER EX is a medical device that received FDA 510(k) clearance on 2021-08-25. It is manufactured by Medos International SARL. The 510(k) number is K210838.

When was PROWLER SELECT PLUS; PROWLER EX approved by the FDA?

PROWLER SELECT PLUS; PROWLER EX received FDA 510(k) clearance on 2021-08-25, under approval number K210838.

What company makes PROWLER SELECT PLUS; PROWLER EX?

PROWLER SELECT PLUS; PROWLER EX is manufactured by Medos International SARL.

What is the FDA product code for PROWLER SELECT PLUS; PROWLER EX?

The FDA product code for PROWLER SELECT PLUS; PROWLER EX is KRA.

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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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