VENTLAB HYPERINFLATION BAG SYSTEM— 510(k) K013308

Name: FDA 510(k) clearance K013308
Creator: U.S. Food and Drug Administration
Published: 2001-12-20

Substantially Equivalent

Ventlab Corp.

FDA 510(k) clearance K013308 for VENTLAB HYPERINFLATION BAG SYSTEM, Substantially Equivalent on 2001-12-20. Applicant: Ventlab Corp.. Device class: 2.

Clearance details

Applicant: Ventlab Corp.
Product code: Code NHK
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2001-10-04
Decision date: 2001-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mocksville, NC, US

Download summary PDF View on FDA.gov ↗

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