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FDA 510(k)

Combined Aerobika OPEP and VersaPAP device

K-Number: K183108 · 2019-08-16

ApplicantTrudell Medical International
Decision Date2019-08-16
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Combined Aerobika OPEP and VersaPAP device is the device name listed in this FDA 510(k) record. The listed applicant is Trudell Medical International. It received FDA 510(k) clearance on 2019-08-16 under 510(k) number K183108. 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 Combined Aerobika OPEP and VersaPAP device?

Combined Aerobika OPEP and VersaPAP device is a medical device that received FDA 510(k) clearance on 2019-08-16. The listed applicant is Trudell Medical International. The 510(k) number is K183108.

When did Combined Aerobika OPEP and VersaPAP device receive FDA 510(k) clearance?

Combined Aerobika OPEP and VersaPAP device received FDA 510(k) clearance on 2019-08-16, under 510(k) number K183108.

Who is the listed applicant for Combined Aerobika OPEP and VersaPAP device?

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

What is the FDA product code for Combined Aerobika OPEP and VersaPAP device?

The FDA product code for Combined Aerobika OPEP and VersaPAP device is BWF.

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Related Devices (Code: BWF)

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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.

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