Spirobank Portable PC Based Spirometer

FDA 510(k) K973456 · Futuremed America, Inc.

Substantially Equivalent

510(k) numberK973456

Submission

Device name
Spirobank Portable PC Based Spirometer
Applicant
Futuremed America, Inc.
Granada Hills, CA, US
Received
September 11, 1997
Decision date
July 22, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
BZG – Spirometer, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1840
Specialty
Anesthesiology

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Questions and answers

When was Spirobank Portable PC Based Spirometer cleared by the FDA?

Spirobank Portable PC Based Spirometer (K973456) received a 510(k) decision of Substantially Equivalent on July 22, 1998, 314 days after the submission was received.

What is the product code of K973456?

The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.