Ergofilter Spi Accessory to Spirolyser SPL-50

FDA 510(k) K050424 · Fim Medical

Substantially Equivalent

510(k) numberK050424

Submission

Device name
Ergofilter Spi Accessory to Spirolyser SPL-50
Applicant
Fim Medical
Deer Field, IL, US
Received
February 18, 2005
Decision date
June 23, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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 Ergofilter Spi Accessory to Spirolyser SPL-50 cleared by the FDA?

Ergofilter Spi Accessory to Spirolyser SPL-50 (K050424) received a 510(k) decision of Substantially Equivalent on June 23, 2005, 125 days after the submission was received.

What is the product code of K050424?

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