Flow Spirometer

FDA 510(k) K934502 · Healthdyne, Inc.

Substantially Equivalent

510(k) numberK934502

Submission

Device name
Flow Spirometer
Applicant
Healthdyne, Inc.
Marietta, GA, US
Received
September 14, 1993
Decision date
April 4, 1994
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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K241338Peak Flow MeterBZH · Traditional Chongqing Moffy Innovation Technology Co., Ltd.12/31/2024SE
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K193311AlunaBZH · Traditional Knox Medical Diagnostics, Inc.03/25/2020SE
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Questions and answers

When was Flow Spirometer cleared by the FDA?

Flow Spirometer (K934502) received a 510(k) decision of Substantially Equivalent on April 4, 1994, 202 days after the submission was received.

What is the product code of K934502?

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