PM2 System with ECGuide Connector
K-Number: K252792 · 2025-11-17
ApplicantPiccolo Medical, Inc.
Decision Date2025-11-17
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
PM2 System with ECGuide Connector is a medical device manufactured by Piccolo Medical, Inc.. It received FDA 510(k) clearance on 2025-11-17 under approval number K252792. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PM2 System with ECGuide Connector?
PM2 System with ECGuide Connector is a medical device that received FDA 510(k) clearance on 2025-11-17. It is manufactured by Piccolo Medical, Inc.. The 510(k) number is K252792.
When was PM2 System with ECGuide Connector approved by the FDA?
PM2 System with ECGuide Connector received FDA 510(k) clearance on 2025-11-17, under approval number K252792.
What company makes PM2 System with ECGuide Connector?
PM2 System with ECGuide Connector is manufactured by Piccolo Medical, Inc..
What is the FDA product code for PM2 System with ECGuide Connector?
The FDA product code for PM2 System with ECGuide Connector is LJS.
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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.