Stryker Consolidated Operating Room Equipment (CORE) 2 Console
K-Number: K171840 · 2017-09-15
ApplicantStryker Corporation
Decision Date2017-09-15
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Stryker Consolidated Operating Room Equipment (CORE) 2 Console is a medical device manufactured by Stryker Corporation. It received FDA 510(k) clearance on 2017-09-15 under approval number K171840. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Stryker Consolidated Operating Room Equipment (CORE) 2 Console?
Stryker Consolidated Operating Room Equipment (CORE) 2 Console is a medical device that received FDA 510(k) clearance on 2017-09-15. It is manufactured by Stryker Corporation. The 510(k) number is K171840.
When was Stryker Consolidated Operating Room Equipment (CORE) 2 Console approved by the FDA?
Stryker Consolidated Operating Room Equipment (CORE) 2 Console received FDA 510(k) clearance on 2017-09-15, under approval number K171840.
What company makes Stryker Consolidated Operating Room Equipment (CORE) 2 Console?
Stryker Consolidated Operating Room Equipment (CORE) 2 Console is manufactured by Stryker Corporation.
What is the FDA product code for Stryker Consolidated Operating Room Equipment (CORE) 2 Console?
The FDA product code for Stryker Consolidated Operating Room Equipment (CORE) 2 Console is ERL.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.