PeriFLEX
K-Number: K162611 · 2017-02-09
ApplicantSpiration, Inc.
Decision Date2017-02-09
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
PeriFLEX is a medical device manufactured by Spiration, Inc.. It received FDA 510(k) clearance on 2017-02-09 under approval number K162611. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PeriFLEX?
PeriFLEX is a medical device that received FDA 510(k) clearance on 2017-02-09. It is manufactured by Spiration, Inc.. The 510(k) number is K162611.
When was PeriFLEX approved by the FDA?
PeriFLEX received FDA 510(k) clearance on 2017-02-09, under approval number K162611.
What company makes PeriFLEX?
PeriFLEX is manufactured by Spiration, Inc..
What is the FDA product code for PeriFLEX?
The FDA product code for PeriFLEX is EOQ.
Other Devices by Spiration, Inc.
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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.