K-number	K190949
Device name	ScanX Barrier Envelopes
Applicant	Air Techniques, Inc.
Product code	PEM
Device class	Class II
Decision date	Jul 26, 2019
Decision	Substantially Equivalent
Regulation	878.4370

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Source

View the full FDA submission: accessdata.fda.gov

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ScanX Barrier Envelopes

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