Freespira
K-Number: K180173 · 2018-08-23
ApplicantPalo Alto Health Sciences, Inc.
Decision Date2018-08-23
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Freespira is a medical device manufactured by Palo Alto Health Sciences, Inc.. It received FDA 510(k) clearance on 2018-08-23 under approval number K180173. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Freespira?
Freespira is a medical device that received FDA 510(k) clearance on 2018-08-23. It is manufactured by Palo Alto Health Sciences, Inc.. The 510(k) number is K180173.
When was Freespira approved by the FDA?
Freespira received FDA 510(k) clearance on 2018-08-23, under approval number K180173.
What company makes Freespira?
Freespira is manufactured by Palo Alto Health Sciences, Inc..
What is the FDA product code for Freespira?
The FDA product code for Freespira is HCC.
Related Devices (Code: HCC)
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.