FDA 510(k)

StealthStationTM S8 ENT Software

K-번호: K170018 · 2017-05-19

결정일2017-05-19

제품 코드PGW

자문 위원회NE

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Medtronic Navigation, Inc.를 신청인으로 등재한 기타 기록

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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