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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 a medical device manufactured by Trudell Medical International. It received FDA 510(k) clearance on 2019-08-16 under approval 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. It is manufactured by Trudell Medical International. The 510(k) number is K183108.

When was Combined Aerobika OPEP and VersaPAP device approved by the FDA?

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

What company makes Combined Aerobika OPEP and VersaPAP device?

Combined Aerobika OPEP and VersaPAP device is manufactured by Trudell Medical International.

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 PubMed Literature

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Other Devices by Trudell Medical International

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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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