FDA 510(k)

StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1

Numéro K : K190672 · 2019-07-31

Date de décision2019-07-31

Code produitHAW

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 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 2019-07-31 under 510(k) number K190672. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1?

StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 is a medical device that received FDA 510(k) clearance on 2019-07-31. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K190672.

When did StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 receive FDA 510(k) clearance?

StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 received FDA 510(k) clearance on 2019-07-31, under 510(k) number K190672.

Who is the listed applicant for StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1?

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 StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1?

The FDA product code for StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 is HAW.

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Source officielle

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