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FDA 510(k)

Sotair Device

K-Number: K212905 · 2022-08-18

ApplicantSafe Bvm Corporation
Decision Date2022-08-18
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Sotair Device is the device name listed in this FDA 510(k) record. The listed applicant is Safe Bvm Corporation. It received FDA 510(k) clearance on 2022-08-18 under 510(k) number K212905. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sotair Device?

Sotair Device is a medical device that received FDA 510(k) clearance on 2022-08-18. The listed applicant is Safe Bvm Corporation. The 510(k) number is K212905.

When did Sotair Device receive FDA 510(k) clearance?

Sotair Device received FDA 510(k) clearance on 2022-08-18, under 510(k) number K212905.

Who is the listed applicant for Sotair Device?

The FDA 510(k) record lists Safe Bvm Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sotair Device?

The FDA product code for Sotair Device is BTM.

Related Devices (Code: BTM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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