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FDA 510(k)

Acapella Choice Blue Vibratory PEP Device

K-Number: K181660 · 2019-10-24

ApplicantSmiths Medical
Decision Date2019-10-24
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Acapella Choice Blue Vibratory PEP Device is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical. It received FDA 510(k) clearance on 2019-10-24 under 510(k) number K181660. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acapella Choice Blue Vibratory PEP Device?

Acapella Choice Blue Vibratory PEP Device is a medical device that received FDA 510(k) clearance on 2019-10-24. The listed applicant is Smiths Medical. The 510(k) number is K181660.

When did Acapella Choice Blue Vibratory PEP Device receive FDA 510(k) clearance?

Acapella Choice Blue Vibratory PEP Device received FDA 510(k) clearance on 2019-10-24, under 510(k) number K181660.

Who is the listed applicant for Acapella Choice Blue Vibratory PEP Device?

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

What is the FDA product code for Acapella Choice Blue Vibratory PEP Device?

The FDA product code for Acapella Choice Blue Vibratory PEP Device is BWF.

Related Devices (Code: BWF)

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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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