SIS System
K-Number: K230977 · 2023-05-02
ApplicantSurgical Information Sciences, Inc.
Decision Date2023-05-02
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SIS System is a medical device manufactured by Surgical Information Sciences, Inc.. It received FDA 510(k) clearance on 2023-05-02 under approval number K230977. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SIS System?
SIS System is a medical device that received FDA 510(k) clearance on 2023-05-02. It is manufactured by Surgical Information Sciences, Inc.. The 510(k) number is K230977.
When was SIS System approved by the FDA?
SIS System received FDA 510(k) clearance on 2023-05-02, under approval number K230977.
What company makes SIS System?
SIS System is manufactured by Surgical Information Sciences, Inc..
What is the FDA product code for SIS System?
The FDA product code for SIS System is QIH.
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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.