Spirosift 500A

FDA 510(k) K904200 · Fukuda Denshi USA, Inc.

Substantially Equivalent

510(k) numberK904200

Submission

Device name
Spirosift 500A
Applicant
Fukuda Denshi USA, Inc.
Redmond, WA, US
Received
September 12, 1990
Decision date
May 22, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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 Spirosift 500A cleared by the FDA?

Spirosift 500A (K904200) received a 510(k) decision of Substantially Equivalent on May 22, 1991, 252 days after the submission was received.

What is the product code of K904200?

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