Name: Predicase
Price: 199 USD

K-number	K252792
Device name	PM2 System with ECGuide Connector
Applicant	Piccolo Medical, Inc.
Product code	LJS
Device class	Class II
Decision date	Nov 17, 2025
Decision	Substantially Equivalent
Regulation	880.5970

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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PM2 System with ECGuide Connector

Everything you need for a 510(k) submission. Nothing you don't.

PM2 System with ECGuide Connector