Multispiro-Breeze

FDA 510(k) K913681 · Multispiro, Inc.

Substantially Equivalent

510(k) numberK913681

Submission

Device name
Multispiro-Breeze
Applicant
Multispiro, Inc.
Irvine, CA, US
Received
August 19, 1991
Decision date
July 2, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
BZC – Calculator, Pulmonary Function Data
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1880
Specialty
Anesthesiology

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More from Innovision A/S

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K920390The PeakBZH · Traditional 09/11/1992SE
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Questions and answers

When was Multispiro-Breeze cleared by the FDA?

Multispiro-Breeze (K913681) received a 510(k) decision of Substantially Equivalent on July 2, 1992, 318 days after the submission was received.

What is the product code of K913681?

The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.