K-number	K192211
Device name	SoundBite Console, SoundBite Active Wire 18
Applicant	Soundbite Medical Solution, Inc.
Product code	PDU
Device class	Class II
Decision date	Jan 17, 2020
Decision	Substantially Equivalent
Regulation	870.1250

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View the full FDA submission: accessdata.fda.gov

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SoundBite Console, SoundBite Active Wire 18

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