Connected OR Hub With Device And Voice Control

Laparoscope, General & Plastic Surgery

Stryker

The following data is part of a premarket notification filed by Stryker with the FDA for Connected Or Hub With Device And Voice Control.

Pre-market Notification Details

Device IDK192172
510k NumberK192172
Device Name:Connected OR Hub With Device And Voice Control
ClassificationLaparoscope, General & Plastic Surgery
Applicant Stryker 5900 Optical Court San Jose,  CA  95131
ContactMeagan Jones
CorrespondentMeagan Jones
Stryker 5900 Optical Court San Jose,  CA  95131
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-12
Decision Date2019-09-09
Summary:summary

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