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FDA 510(k)

WATCHHALER

K-Number: K080100 · 2008-06-30

ApplicantActivaero America, Inc.
Decision Date2008-06-30
Product CodeNVP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WATCHHALER is the device name listed in this FDA 510(k) record. The listed applicant is Activaero America, Inc.. It received FDA 510(k) clearance on 2008-06-30 under 510(k) number K080100. The device is classified under product code NVP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WATCHHALER?

WATCHHALER is a medical device that received FDA 510(k) clearance on 2008-06-30. The listed applicant is Activaero America, Inc.. The 510(k) number is K080100.

When did WATCHHALER receive FDA 510(k) clearance?

WATCHHALER received FDA 510(k) clearance on 2008-06-30, under 510(k) number K080100.

Who is the listed applicant for WATCHHALER?

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

What is the FDA product code for WATCHHALER?

The FDA product code for WATCHHALER is NVP.

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Other records listing Activaero America, Inc. as applicant

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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Related Devices (Code: NVP)

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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