Pseudo-Patient
K-Number: K180697 · 2018-07-10
ApplicantRtsafe, Inc.
Decision Date2018-07-10
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Pseudo-Patient is a medical device manufactured by Rtsafe, Inc.. It received FDA 510(k) clearance on 2018-07-10 under approval number K180697. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Pseudo-Patient?
Pseudo-Patient is a medical device that received FDA 510(k) clearance on 2018-07-10. It is manufactured by Rtsafe, Inc.. The 510(k) number is K180697.
When was Pseudo-Patient approved by the FDA?
Pseudo-Patient received FDA 510(k) clearance on 2018-07-10, under approval number K180697.
What company makes Pseudo-Patient?
Pseudo-Patient is manufactured by Rtsafe, Inc..
What is the FDA product code for Pseudo-Patient?
The FDA product code for Pseudo-Patient is IYE.
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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.