Spirit, Model Has

510(k) K050153

Listed No authorization on record

Valid until

Not applicable

No authorization on record

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Specification

510(k)

510(k) Number: K050153
FDA Product Code: BYJ
FDA applicant: Caire, Inc.

Device Class: Class II
Regulation: 21 CFR Part 868.5655
Advisory Committee: Anesthesiology
FDA Decision: SESE Substantially Equivalent

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