FDA 510(k)

Software StealthStationTM S8 ENT

Número K: K170018 · 2017-05-19

Data da decisão2017-05-19

Código do produtoPGW

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

StealthStationTM S8 ENT Software is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2017-05-19 under 510(k) number K170018. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the StealthStationTM S8 ENT Software?

StealthStationTM S8 ENT Software is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K170018.

When did StealthStationTM S8 ENT Software receive FDA 510(k) clearance?

StealthStationTM S8 ENT Software received FDA 510(k) clearance on 2017-05-19, under 510(k) number K170018.

Who is the listed applicant for StealthStationTM S8 ENT Software?

The FDA 510(k) record lists Medtronic Navigation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for StealthStationTM S8 ENT Software?

The FDA product code for StealthStationTM S8 ENT Software is PGW.

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Outros registros que listam Medtronic Navigation, Inc. como candidato(a)

K253379Stealth AXiS Cranial clinical application K253395Stealth AXiS™ ENT clinical application K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application K251282StealthStation S8 Spine Software K242464Stealth™ Spine Clamps; ModuLeX™ Shank Mounts

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Dispositivos Relacionados (Código: PGW)

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Fonte oficial

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