Name: Predicase
Price: 199 USD

K-number	K251631
Device name	The BAG manual resuscitator and accessories
Applicant	Laerdal Medical AS
Product code	BTM
Device class	Class II
Decision date	Nov 24, 2025
Decision	Substantially Equivalent
Regulation	868.5915

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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The BAG manual resuscitator and accessories

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