ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50— 510(k) K050424

Substantially Equivalent

Fim Medical

FDA 510(k) clearance K050424 for ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50, Substantially Equivalent on 2005-06-23. Applicant: Fim Medical. Device class: 2.

Clearance details

Applicant
Fim Medical
Product code
Code BZG
Device class
Class 2
Regulation
21 CFR 868.1840
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Deer Field, IL, US
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