Aspire

FDA 510(k) K936110 · Dura Pharmaceuticals, Inc.

Substantially Equivalent

510(k) numberK936110

Submission

Device name
Aspire
Applicant
Dura Pharmaceuticals, Inc.
San Diego, CA, US
Received
December 23, 1993
Decision date
March 23, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
BZH – Meter, Peak Flow, Spirometry
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1860
Specialty
Anesthesiology

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Questions and answers

When was Aspire cleared by the FDA?

Aspire (K936110) received a 510(k) decision of Substantially Equivalent on March 23, 1995, 455 days after the submission was received.

What is the product code of K936110?

The FDA product code is BZH – Meter, Peak Flow, Spirometry, a Class II (moderate risk) device regulated under 21 CFR 868.1860.