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FDA 510(k)

ASPIRE

K-Number: K936110 · 1995-03-23

ApplicantDura Pharmaceuticals, Inc.
Decision Date1995-03-23
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ASPIRE is the device name listed in this FDA 510(k) record. The listed applicant is Dura Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1995-03-23 under 510(k) number K936110. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASPIRE?

ASPIRE is a medical device that received FDA 510(k) clearance on 1995-03-23. The listed applicant is Dura Pharmaceuticals, Inc.. The 510(k) number is K936110.

When did ASPIRE receive FDA 510(k) clearance?

ASPIRE received FDA 510(k) clearance on 1995-03-23, under 510(k) number K936110.

Who is the listed applicant for ASPIRE?

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

What is the FDA product code for ASPIRE?

The FDA product code for ASPIRE is BZH.

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Other records listing Dura Pharmaceuticals, 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.

K896984PARI I.S.-2K894555PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED

Related Devices (Code: BZH)

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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