SoundBite Console, SoundBite Active Wire 18
K-Number: K192211 · 2020-01-17
ApplicantSoundbite Medical Solution, Inc.
Decision Date2020-01-17
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
SoundBite Console, SoundBite Active Wire 18 is a medical device manufactured by Soundbite Medical Solution, Inc.. It received FDA 510(k) clearance on 2020-01-17 under approval number K192211. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SoundBite Console, SoundBite Active Wire 18?
SoundBite Console, SoundBite Active Wire 18 is a medical device that received FDA 510(k) clearance on 2020-01-17. It is manufactured by Soundbite Medical Solution, Inc.. The 510(k) number is K192211.
When was SoundBite Console, SoundBite Active Wire 18 approved by the FDA?
SoundBite Console, SoundBite Active Wire 18 received FDA 510(k) clearance on 2020-01-17, under approval number K192211.
What company makes SoundBite Console, SoundBite Active Wire 18?
SoundBite Console, SoundBite Active Wire 18 is manufactured by Soundbite Medical Solution, Inc..
What is the FDA product code for SoundBite Console, SoundBite Active Wire 18?
The FDA product code for SoundBite Console, SoundBite Active Wire 18 is PDU.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.