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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Soundbite Medical Solution, Inc.. It received FDA 510(k) clearance on 2020-01-17 under 510(k) 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. The listed applicant is Soundbite Medical Solution, Inc.. The 510(k) number is K192211.

When did SoundBite Console, SoundBite Active Wire 18 receive FDA 510(k) clearance?

SoundBite Console, SoundBite Active Wire 18 received FDA 510(k) clearance on 2020-01-17, under 510(k) number K192211.

Who is the listed applicant for SoundBite Console, SoundBite Active Wire 18?

The FDA 510(k) record lists Soundbite Medical Solution, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: PDU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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