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FDA 510(k)

PnueAira (PNCU-01)

K-Number: K251086 · 2025-08-18

ApplicantBiotab, LLC
Decision Date2025-08-18
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PnueAira (PNCU-01) is the device name listed in this FDA 510(k) record. The listed applicant is Biotab, LLC. It received FDA 510(k) clearance on 2025-08-18 under 510(k) number K251086. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PnueAira (PNCU-01)?

PnueAira (PNCU-01) is a medical device that received FDA 510(k) clearance on 2025-08-18. The listed applicant is Biotab, LLC. The 510(k) number is K251086.

When did PnueAira (PNCU-01) receive FDA 510(k) clearance?

PnueAira (PNCU-01) received FDA 510(k) clearance on 2025-08-18, under 510(k) number K251086.

Who is the listed applicant for PnueAira (PNCU-01)?

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

What is the FDA product code for PnueAira (PNCU-01)?

The FDA product code for PnueAira (PNCU-01) is JOW.

Related Devices (Code: JOW)

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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