K-number	K182956
Device name	Puffin Lite Infant Resuscitation System
Applicant	International Biomedical
Product code	BTL
Device class	Class II
Decision date	Jan 18, 2019
Decision	Substantially Equivalent
Regulation	868.5925

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Source

View the full FDA submission: accessdata.fda.gov

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Puffin Lite Infant Resuscitation System

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