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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 the device name listed in this FDA 510(k) record. The listed applicant is S.L.P. , Ltd.. It received FDA 510(k) clearance on 2020-04-09 under 510(k) 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. The listed applicant is S.L.P. , Ltd.. The 510(k) number is K191574.

When did OxSAT 100 receive FDA 510(k) clearance?

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

Who is the listed applicant for OxSAT 100?

The FDA 510(k) record lists S.L.P. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OxSAT 100?

The FDA product code for OxSAT 100 is DQA.

Related Devices (Code: DQA)

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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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