eRapid with eTrack System
K-Number: K251572 · 2025-12-19
ApplicantPari Respiratory Equipment, Inc.
Decision Date2025-12-19
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
eRapid with eTrack System is a medical device manufactured by Pari Respiratory Equipment, Inc.. It received FDA 510(k) clearance on 2025-12-19 under approval number K251572. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the eRapid with eTrack System?
eRapid with eTrack System is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Pari Respiratory Equipment, Inc.. The 510(k) number is K251572.
When was eRapid with eTrack System approved by the FDA?
eRapid with eTrack System received FDA 510(k) clearance on 2025-12-19, under approval number K251572.
What company makes eRapid with eTrack System?
eRapid with eTrack System is manufactured by Pari Respiratory Equipment, Inc..
What is the FDA product code for eRapid with eTrack System?
The FDA product code for eRapid with eTrack System is CAF.
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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.