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FDA 510(k)

OxSAT 100

K-Number: K191574 · 2020-04-09

ApplicantS.L.P. , Ltd.
Decision Date2020-04-09
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OxSAT 100 is a medical device manufactured by S.L.P. , Ltd.. It received FDA 510(k) clearance on 2020-04-09 under approval number K191574. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OxSAT 100?

OxSAT 100 is a medical device that received FDA 510(k) clearance on 2020-04-09. It is manufactured by S.L.P. , Ltd.. The 510(k) number is K191574.

When was OxSAT 100 approved by the FDA?

OxSAT 100 received FDA 510(k) clearance on 2020-04-09, under approval number K191574.

What company makes OxSAT 100?

OxSAT 100 is manufactured by S.L.P. , Ltd..

What is the FDA product code for OxSAT 100?

The FDA product code for OxSAT 100 is DQA.

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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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