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FDA 510(k)

Pylant Monitor

K-Number: K191858 · 2020-02-24

ApplicantKal-Med, LLC
Decision Date2020-02-24
Product CodeBSK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Pylant Monitor is a medical device manufactured by Kal-Med, LLC. It received FDA 510(k) clearance on 2020-02-24 under approval number K191858. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pylant Monitor?

Pylant Monitor is a medical device that received FDA 510(k) clearance on 2020-02-24. It is manufactured by Kal-Med, LLC. The 510(k) number is K191858.

When was Pylant Monitor approved by the FDA?

Pylant Monitor received FDA 510(k) clearance on 2020-02-24, under approval number K191858.

What company makes Pylant Monitor?

Pylant Monitor is manufactured by Kal-Med, LLC.

What is the FDA product code for Pylant Monitor?

The FDA product code for Pylant Monitor is BSK.

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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.

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