Fukuda Sangyo Model Spiroanalyzer ST-180

FDA 510(k) K943546 · Spirosoft Northamerica, Inc.

Substantially Equivalent

510(k) numberK943546

Submission

Device name
Fukuda Sangyo Model Spiroanalyzer ST-180
Applicant
Spirosoft Northamerica, Inc.
Tustin, CA, US
Received
July 21, 1994
Decision date
February 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
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 Fukuda Sangyo Model Spiroanalyzer ST-180 cleared by the FDA?

Fukuda Sangyo Model Spiroanalyzer ST-180 (K943546) received a 510(k) decision of Substantially Equivalent on February 23, 1995, 217 days after the submission was received.

What is the product code of K943546?

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