LUNG FUNCTION AMPLIFIER EXERCISER— 510(k) K790744

Name: FDA 510(k) clearance K790744
Creator: U.S. Food and Drug Administration
Published: 1979-04-27

Substantially Equivalent

Empire Plastics Manufacturer

FDA 510(k) clearance K790744 for LUNG FUNCTION AMPLIFIER EXERCISER, Substantially Equivalent on 1979-04-27. Applicant: Empire Plastics Manufacturer. Device class: 2.

Clearance details

Applicant: Empire Plastics Manufacturer
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 1979-04-16
Decision date: 1979-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.